MAUDE Adverse Event Report: BIOMERIEUX ESPAÑA CHROMID® CPS ELITE OPAQUE AGAR

Catalog Number	418206
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of a potential specificity issue associated with chromid cps elite opaque agar (ref.418206, lot.#1007274960, exp.Date: 08-aug-2019).The customer stated having obtained pink colonies for an enterobacter cloacae strain.Pink colonies on this medium are to indicate escherichia coli species.The strain was confirmed as enterobacter cloacae species by mass spectrometry.The following limitation is included in the associated instructions for use (ifu): "certain species may produce colonies of the same characteristic color as e.Coli (ex: citrobacter)." some enterobacter cloacae could have beta-glucuronidase activity (or beta-galactosidase) that could lead to pink colonies.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a specificity issue associated with chromid cps elite opaque agar (ref.418206, lot.#1007274960, exp.Date: 08-aug-2019).A review of manufacturing quality control records confirmed conformity of the lot, and ph and microbiological performances were in accordance with specifications requirements.Retained samples of customer lots 1007230410 and 1007274960, a fresh lot 1007439620, and two other lots close to expiration (1007260490, exp 04-08-2019 and 1007285880, exp 23/10/2019) were inoculated using routine strains, plus additional strains from the internal lab collection.E.Coli atcc 25922, p.Mirabilis atcc 12453, e.Faecalis atcc 29212, k.Pneumoniae atcc 13883, s.Agalactiae atcc 12386 and e.Coli 990604 : routine strains tested.Enterobacter cloacae atcc 13047, citrobacter freundii 8090 and enterobacter aerogenes atcc 13048: additional strains added.Clinical strain received by the customer : confirmed by vitek 2 system to be e.Cloacae as reported by the customer.The results of the routine and additional strains, showed the color conformed to the specifications: e.Coli strains: red to burgundy coloration due to beta-gur and/or beta-gal activity.Enterococcus: turquoise coloration due to beta- glu activity.Kesc : green coloration due to beta-glu activity.Proteae: brown coloration due to deaminase activity.For the clinical strain received from the customer for investigation, the pink color the customer obtained was confirmed on all batches tested.An observation of an atypical enzymatic profile for this strain of enterobacter cloacae: beta-gal positive, and beta-gur negative.Based on the principle of this media defined in the instructions for use, this atypical strain gave the expected color of strain with a beta-gal activity.This is also covered in the limitations of the method "certain species may produce colonies of the same characteristic color as e.Coli (ex: citrobacter)".A review of complaints for the impacted lots 1007230410 & 1007274960 confirmed there was no other complaint on either lot.Statistical trend analysis did not find any systemic issue for either lot related with a false positive issue.In conclusion, chromid cps elite opaque agar performed as intended.

• Brand Name: CHROMID® CPS ELITE OPAQUE AGAR
• Common Device Name: CHROMID® CPS ELITE OPAQUE AGAR
• Manufacturer (Section D): BIOMERIEUX ESPAÑA; isaac newton, 6; tres cantos; madrid, 28760 ; SP 28760
• MDR Report Key: 8826233
• Report Number: 3009307598-2019-00003
• Device Sequence Number: 2562529
• Product Code: JXA
• UDI-Device Identifier: 03573026468170
• UDI-Public: 03573026468170
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2019
• Device Catalogue Number: 418206
• Device Lot Number: 1007274960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1