MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA SARS COV-2; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number PRD-06419

Device Problem Off-Label Use (1494)

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

Event Date 10/23/2022

Event Type  malfunction  

Manufacturer Narrative

Customer admitted to carelessness when preparing reagents and not checking the master lots of the refrigerated and room temperature components, which would be considered off-label use.Hologic technical support (ts) reviewed logs and found no instrument issues.Since this event was considered off package insert, ts was unable to provide review regarding reagent prep.Ts advised customer to discard the remaining of the prepared kits with mismatched master lots, as well as the unused components of these master lots.Customer understood and reported no further issues.As part of eua agreement, fda requires all aptima sars-cov-2 assay questioning results and false results (confirmed or not) complaints to be reported as malfunction mdr.

Event Description

Customer reported accidentally mixing sars-cov-2 tma reagents from different lots, which constitutes as off-label use.Customer used assay lot 315550 (room temperature reagents) with assay lot 317372 (refrigerated reagents) and ran patient samples on panther instrument sn (b)(4).The affected worklist, wl (b)(4), had 8 patient samples.Customer admitted the operator did not match the lots like they were supposed to and grabbed random boxes to mix, confirming this was an operator error.The information provided by the customer was insufficient to characterize any sample as a confirmed false result.Customer confirmed that the results were reported, but the lab supervisor decided to not amend results.There were no associated/reported adverse events or patient impact reported.

• Brand Name: APTIMA SARS COV-2
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: kyleigh jacobs ; 10210 genetic center drive; san diego, CA 92121 ; 8584108566
• MDR Report Key: 15761567
• MDR Text Key: 307889135
• Report Number: 2024800-2022-01103
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06419
• Device Lot Number: 315550 / 317372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1