MAUDE Adverse Event Report: ABBOTT MOLECULAR INC. ABBOTT REALTIME SARS-COV-2 ASSAY REAGENT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Model Number M2000

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Event Description

We have been experiencing issues on our abbott sars-cov-2 assay reagents [covid testing related].The amplification reagent packs which contain 3 different reagent bottles either have insufficient volumes in them or bone dry empty.These cause errors when running the sars-cov-2 on our abbott m2000 instrument and poses delays in our testing.To temporarily mitigate issue, we have been manually measuring out the volumes in each reagent bottle.This temporary solution might pose risk of introducing contaminants into the reagent bottles.We have the option to use a new lot but this would be the 2nd lot of reagents we are having this issue with.Affected lot numbers are 508769 (exp 11/11/21) and 508458 (exp 11/29/21).Manufacturer response for abbott sars-cov-2 assay reagent, abbott sars-cov-2 assay reagent (per site reporter).Investigation of problem is still in place.Received ticket numbers for our cases.

• Brand Name: ABBOTT REALTIME SARS-COV-2 ASSAY REAGENT
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ABBOTT MOLECULAR INC.; 1300 east touhy avenue; des plaines IL 60018
• MDR Report Key: 10717560
• MDR Text Key: 212531079
• Report Number: 10717560
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M2000
• Device Lot Number: 508769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1