MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ MRSA XT; SYSTEM, NUCLEIC ACID AMPLIFICATION TEST

Model Number 443461

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd max¿ mrsa xt a false negative result was obtained by the laboratory personnel.A cepheid test was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported by the customer that there was a false negative result while using cat 443461 lot 1203082.".

Manufacturer Narrative

H6: investigation: the complaint investigation for discrepant results with the kit bd max mrsa xt (ref.(b)(4)) lot 1203082 was performed by the review of the manufacturing records, retain material testing, review of customer¿s data and verification of complaints history.Review of the manufacturing records of bd max mrsa xt indicated that the lot was manufactured according to specifications.The retain material of bd max mrsa xt from lot 1203082 was tested in positive.All reactions gave positive results, as expected.Customer reported a false negative result on a patient sample with the bd max¿ mrsa xt assay from lot 1203082.The sample was retested with the genexpert mrsa assay and gave a mrsa positive result.Customer provided one run file (#4842) from instrument ct0741 for investigation.Run 4842 contained 11 samples tested with the bd max¿ mrsa xt assay lot 1203082.Sample analyzed in position b11, identified as false negative by the customer, gave a mrsa negative result.Manual curves adjudication was performed for this sample and revealed a true amplification in the mrej target (fam channel) and no amplification in the rox channel.Since both targets must amplify in order to give a mrsa positive result, it explains why this sample resulted in a negative result.No anomaly was observed in the curves.As mentioned in the package insert, results such as those obtained for this sample could correspond to a meca/c drop out s.Aureus strain.However, since no sample was received for the investigation, it is not possible to confirm this hypothesis.Overall, no reagents issue is suspected.There is no indication of an increase in complaints for discrepant results for the bd max mrsa xt kit lot 1203082.The root cause was not identified.Is it possible that the discrepant results can be explained by a meca/c drop out s.Aureus strain.The reagents are not suspected of being in cause.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action plan (capa).Bd quality will continue to monitor for trends.

Event Description

It was reported that while using bd max¿ mrsa xt a false negative result was obtained by the laboratory personnel.A cepheid test was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it was reported by the customer that there was a false negative result while using cat 443461 lot 1203082.".

• Brand Name: BD MAX¿ MRSA XT
• Type of Device: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13031535
• MDR Text Key: 287107115
• Report Number: 3007420875-2021-00065
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 00382904434618
• UDI-Public: 00382904434618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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
• Device Operator: Other
• Device Expiration Date: 11/07/2022
• Device Model Number: 443461
• Device Catalogue Number: 443461
• Device Lot Number: 1203082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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