MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® SARS-COV-2 & INFLUENZA A/B; COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES

Catalog Number 09211101190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is in progress.A supplemental mdr report will be submitted once the investigation is completed.Facility name: the facility's full name (laboklin labor für klinische diagnostik gmbh & co.Kg) has been truncated due to character limitations.Cn- (b)(4).

Event Description

In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer from germany alleged two discrepant results for two patients while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.For patient one, the alleged sample initially generated a positive result for sars-cov-2.A recollected sample was retested on the same cobas® liat® system which yielded a negative result for all targets.For patient two, the alleged sample initially generated a positive result for sars-cov-2.The same sample was retested on the same cobas® liat® system which yielded a negative result for all targets.Although requested, information regarding which results reported as well as sample collection information was not provided.No harm was alleged.An investigation is in progress to evaluate the customer issue.Per fda¿s eua guidance, 2 mdrs will be filed.

Manufacturer Narrative

This is a follow-up report to provide the case conclusion for 2243471-2022-00406.For runs 436 & 506, true amplification can be observed in the respective channels.Further analysis was performed and no system related issue was identified.The customer was using throat swabs, which are off-label and may have contributed to the discrepancy experienced.Inadequate or inappropriate sample collection, storage, and transport may yield incorrect or invalid test results.Investigation was performed to evaluate the customer issue and no product problem related to the customer allegation was identified.(b)(4).

Event Description

The customer was able to confirm that both positive results were reported.

• Brand Name: COBAS® SARS-COV-2 & INFLUENZA A/B
• Type of Device: COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 14118643
• MDR Text Key: 298810074
• Report Number: 2243471-2022-00406
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EUA201779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 09211101190
• Device Lot Number: 11220L
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1