MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA

Catalog Number 43451

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer from (b)(6) reported to biomérieux a false positive (b)(6) result for a multi-resistant patient isolate in association with chromid® (b)(6) 20 plt.The customer reported the (b)(6) isolate was cultured on the chromid® (b)(6) and the isolate grew only the (b)(6) lot.The customer reported patient results were affected as infection control acts on presumptive positives that are green on chromid® agar.The patient was isolated with other colonized (b)(6) positive patients due to this result and was possibly exposed to truly positive (b)(6) patients.The customer stated there was a delay in reporting results as sensitivity testing and further testing had to be performed due to the discrepancy.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This investigation was initiated because five (b)(6) customers reported (b)(6) results for chromid® mrsa agar, reference 43451.Five (5) different lot numbers of reference 43451 were impacted; 1005582870, expiry 07 june 2017, 1005646630, expiry 05 july 2017, 1005639900, expiry 30 june 2017, 1005696340, expiry 28 july 2017, 1005600420, expiry 14 june 2017.The customers reported that growth of green colonies was observed after incubation for nasal, throat, and other specimens.The customers reported the following protocols: the first customer: nasal swabs, direct inoculation, reading time at 24hrs and at 48hrs.The second customer: nasal swabs and other specimens.The third customer: nasal and throat swabs, incubation 24hrs and 48hrs of incubation at 35c.The fourth customer: nasal and throat swabs, direct inoculation, incubation at 35c,aerobic conditions, reading at 48hrs.The fifth customer: nasal and throat swabs, direct inoculation, incubation 24hrs and 48hrs, green colonies observed at 48hrs.Chromid® mrsa, reference 43451, was provided to (b)(6) customers instead of chromid® mrsa reference 04924 from (b)(6) 2017 due to a capacity issue at the production site in (b)(6).Shipping conditions from (b)(6) to (b)(6) for the impacted lot numbers conformed to specifications.Products were received in (b)(6) for the five impacted lot numbers according to procedure (b)(4) "time and temperature monitoring procedure".The australian site has returned to manufacturing their local product reference 04924.This investigation involved a review of complaints registered for the impacted lot numbers, a file review of the impacted lot numbers and analyses of the retained biomérieux sample plates.On 31-oct-2017, a review of the complaints registered for the impacted lot numbers indicated that no other complaints were recorded apart from the complaints in question.File review of the impacted lot numbers indicated the following: lot number 1005582870 was separated on the 22-mar-2017 on line a2 from 07h39 to 14h48.2537 kits were manufactured with an expiry date of 07-june-2017.Five tanks of bulk agar were used in the manufacturing of the product.Five pools of chromid® mrsa additive were used in the manufacturing of the product.The microbiological state and appearance of the product was quality controlled; 128 plates were incubated at 20-25c, 139 plates were incubated at 33-37c.All plates conformed to specifications.Lot number 1005646630 was separated on the 19-apr-2017 on line a2 from 11h27 to 15h22.1581 kits were manufactured with an expiry date of 05-july-2017.Three tanks of bulk agar were used in the manufacturing of the product.Three pools of chromid® mrsa additive were used in the manufacturing of the product.The microbiological state and appearance of the product was quality controlled; 108 plates were incubated at 20-25c, 119 plates were incubated at 33-37c.All plates conformed to specifications.Lot number 1005639900 was separated on the 14-apr-2017 on line a5 from 07h00 to 12h14.2225 kits were manufactured with an expiry date of 30-june-2017.Two tanks of bulk agar were used in the manufacturing of the product.Four pools of chromid® mrsa additive were used in the manufacturing of the product.The microbiological state and appearance of the product was also quality controlled; 128 plates were incubated at 20-25c, 123 plates were incubated at 33-37c.All plates conformed to specifications.Lot number 1005696340 was separated on the 12-may-2017 on line a5 from 06h15 to 12h16.3039 kits were manufactured with an expiry date of 28-july-2017.Three tanks of bulk agar were used in the manufacturing of the product.Five pools of chromid® mrsa additive were used in the manufacturing of the product.The microbiological state and appearance of the product was quality controlled; 158 plates were incubated at 20-25c, 159 plates were incubated at 33-37c.All plates conformed to specifications.Lot number 1005600420 was separated on the 29-mar-2017 on line a5 from 18h38 to 00h38.3157 kits were manufactured with an expiry date of 14-june-2017.Three tanks of bulk agar were used in the manufacturing of the product.Five pools of chromid® mrsa additive were used in the manufacturing of the product.The microbiological state and appearance of the product was also quality controlled; 167 plates were incubated at 20-25c, 170 plates were incubated at 33-37c.All plates conformed to specifications.For all the impacted lot numbers reviewed; the quality control of the weight of the product conformed to specifications for the duration of the manufacturing process.The quality control certificate conformed to specifications for the product's appearance, color, ph, microbiological activity and microbiological state.The technical laboratory quality controls indicated that the quality controls conformed to microbiological activity specifications.The following controls were tested; staphylococcus aureus atcc 43300 bmr, staphylococcus aureus atcc 29213, escherichia coli atcc 8739, candida albicans atcc 10231, enterococcus faecalis atcc 29212, staphylococcus aureus 05-04-605, staphylococcus aureus 05-06-614, enterococcus faecalis atcc 29212, staphylococcus aureus atcc 43300 bmr.Analyses of the retained biomérieux sample plates indicated the following: retained sample plates, manufactured at various different times, 07h09, 07h34, 08h31, 08h59, 09h53, 11h08, 12h15 were analyzed for the impacted lot number 1005696340.The sample plates were tested for microbiological activity in parallel with a reference lot number 1005675150.The four other impacted lot numbers were not tested as they had expired at the time of the analyses.The following results were obtained for quality control strains resistant to (b)(6): staphylococcus aureus atcc 43300; good growth of green colonies at 18hrs and 24hrs on the impacted lot and the reference lot.The following results were obtained for quality control strains sensitive to (b)(6): staphylococcus aureus atcc 29213; total inhibition at 48hrs on the impacted lot and the reference lot.The results of the quality controls for all other atcc strains tested conformed with specifications; escherichia coli atcc 8739, enterococcus faecalis atcc 29212 and candida albians atcc 10231.The microbiological activity of a wild strain of (b)(6) sensitive to (b)(6) was tested on four lot numbers at different stages of their shelf life; two lots close to expiry date, one lot at the middle of its shelf life and one lot at the start of its shelf life.The following lot numbers were tested 1005709850 (10 weeks), 1005730980 (9 weeks), 1005803700 (4 weeks) and 1005853090 (1 week).Expected total inhibition results were obtained; results conformed to specifications.The testing performed did not indicate a drift in performance for chomid® mrsa reference 43451.Analyses of the raw material used in the manufacturing of the above lot numbers, dry media, reference 6006678 and cefoxitine reference 00768116, did not indicate a non-conformity for the lot numbers of raw material used in the manufacturing of the impacted lot numbers.In conclusion, a review of the complaints registered for the impacted lot numbers indicated that no other complaints were recorded apart from the complaints in question.File reviews of the five impacted lot numbers indicated that the lot numbers conformed to specifications.The analyses performed as part of the investigation did not indicate a drift in performance for chromid® mrsa agar, reference 43451 nor a non-conformity linked to the raw material used in the manufacturing of the product.Of note, the package insert for chomid® mrsa reference 43451 states; " after 18-24 hours of incubation, for nose specimens, a green color is characteristic of mrsa.For the other types of specimens the typical colonies must be identified using biochemical or immunological tests (s.Aureus).If identification of s.Aureus is confirmed, check the resistance of the strain to methicillin.After 48 hours of incubation and whatever the type of specimen, the typical colonies should be identified following the same procedure." the australian site has returned to manufacturing their local product, chromid® mrsa agar, reference 04924.Neither corrective nor preventive actions will be implemented as the product chromid® mrsa agar, reference 43451 is performing within specification.

• Brand Name: CHROMID® MRSA
• Type of Device: CHROMID® MRSA
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6751003
• MDR Text Key: 81362444
• Report Number: 3002769706-2017-00211
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K091024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 43451
• Device Lot Number: 1005639900
• Other Device ID Number: 03573026136642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention