MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HIV AG/AB COMBO REAGENT KIT; TEST, HIV DETECTION

Catalog Number 08P07-22

Device Problem False Positive Result (1227)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer identified (b)(6) alinity i (b)(6) combo results for one patient.The following information was provided: (b)(6).No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 22561be00.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A retained reagent kit of lot number 22561be00 was tested; the lot generated the expected results.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity i hiv ag/ab combo reagent lot number 22561be00 was identified.

• Brand Name: ALINITY I HIV AG/AB COMBO REAGENT KIT
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12300646
• MDR Text Key: 265817757
• Report Number: 3002809144-2021-00475
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2021
• Device Catalogue Number: 08P07-22
• Device Lot Number: 22561BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI04617; ALNTY I PROCESSING MODU, 03R65-01, AI04617; ALNTY I PROCESSING MODU, 03R65-01, AI04617