MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ STAPHSR; ANTIMICROBIAL SUSCEPTIBILITY TEST POWDER

Catalog Number 443419

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Death (1802)

Event Date 12/07/2017

Event Type  Death  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an erroneous result from a bd max¿ staphsr lead to a change in treatment for a hospitalized patient.Result was later updated and treatment changed to treat diagnosis.Patient expired five day later.

Manufacturer Narrative

Investigation summary: investigation (b)(4) was completed on 2018-01-08.This complaint concerned two patient samples that gave a (b)(6) result with the bd max¿ staphsr assay but were identified as (b)(6) by culture determination methods.The investigation consisted in verification of the manufacturing records and qc data of the bd max¿ staphsr assay kit lot 7199956, as well as analysis of the customer¿s databases and testing of the retained material of this lot.Qc data of the bd max¿ staphsr assay kit lot 7199956 were all conforming and no negative result was obtained during the positive testing of this kit.Moreover, testing of the retained material gave the expected results, within the trends.The positive test of the retained material from lot 7199956 confirmed that the product still performed as expected.Three databases were available for this investigation, for the analysis of the discrepant patient samples.Two patient samples were identified as discrepant following repeated tests with bd max¿ staphsr assay and culture determination methods.The two samples gave strong amplification curves for the meca/c (rox) and (b)(6).Aureus (vic) targets, with no amplification for the mrej target (fam; (b)(6)).Pure isolates were also tested by the customer, following the pi guidelines, and confirmed the previous bd max staphsr (b)(6) results.Those two isolates were also sent to another facility to be tested with the genexpert® assay where one of the samples came back (b)(6).Those results suggest that the two samples contained (b)(6) strains of a mrej type not detected by the bd max staphsr assay.However, since no sample was received for investigation, this hypothesis could not be confirmed.Our clinical studies have shown that such undetected (b)(6) variant strains are rare and represent only a minor population of all the (b)(6) strains.Quality was informed of the results of this investigation.Investigation conclusion: the complaint of (b)(6) results with the bd max staphsr lot 7199956 was not confirmed.The investigation was performed by the review of the manufacturing records, customer¿s data analysis, retainer testing and review of the complaints history.Manufacturing records review indicated that the qc inspection met the product acceptance criteria and no (b)(6) result was obtained.According to the customer, the testing was performed by sampling blood straight from the culture bottle which is an off-label product use.According to the customer, two samples ((b)(6)) were reported (b)(6) with the bd max staphsr assay while it was reported (b)(6) using culture method.Three databases were submitted for analysis.The investigation revealed that the two samples gave strong amplification curves for the meca/c (rox) and staph.Aureus (vic) targets.However, no amplification occurred for the mrej target (fam; (b)(6)).Pure isolates were also tested by the customer and the results were the same, no amplification for the mrej target (fam; (b)(6)).These results suggests that the samples contained an (b)(6) not detected by the bd max staphsr assay.According to the customer, the pure isolates were also tested using alternate pcr method (genexpert).One sample was reported (b)(6) and the second was reported (b)(6).These results suggests that at least one sample contained an (b)(6) strain not detected by the genexpert.The retainer material was tested and the results were all conforming and no (b)(6) result was obtained.The exact cause of the customer¿s issue is unknown, but it is suspected that the samples contained (b)(6) cells not detected by our assay.Since no samples were submitted for the investigation, no conclusions could be drawn.There is no trend of complaint for (b)(6) results for the bd max staphsr assay.No corrective and preventive action (capa) plan was initiated at this moment.Bd apologizes for the inconvenience that this may have caused.Bd life sciences quality will continue to monitor for trends.Update risk management file : no update required since the complaint is not confirmed.Root cause description: the exact cause of the customer¿s issue is unknown, but it is suspected that the samples contained (b)(6) cells not detected by our assay.

• Brand Name: BD MAX¿ STAPHSR
• Type of Device: ANTIMICROBIAL SUSCEPTIBILITY TEST POWDER
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7151439
• MDR Text Key: 95952314
• Report Number: 3007420875-2017-00001
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 00382904434199
• UDI-Public: 00382904434199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/11/2018
• Device Catalogue Number: 443419
• Device Lot Number: 7199956
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2017
• 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): Death