MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HAVAB IGM REAGENT KIT; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number 02R28-32

Device Problem False Negative Result (1225)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).This report is being filed on an international product, list number 2r28 that has a similar product distributed in the us, list number 8p28.

Event Description

The customer generated (b)(6) alinity i havab igm results for two patients in comparison to external labs.The following information was provided: sid (b)(6) initial 0.82 (grayzone), repeat 0.59 ((b)(6)), outside lab (b)(6).Sid (b)(6) initial 0.88 (grayzone), repeat 0.58 ((b)(6)), outside lab (b)(6).No impact to patient management was reported.

Manufacturer Narrative

D4 - the catalog number has been corrected to 02r28-32 h6 health effect impact code: f26 component code: g01003 d8 was this device serviced by a third party? no a review of tickets was performed for reagent lot number 18550be00.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 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 havab igm reagent lot number 18550be00 was identified.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

Manufacturer Narrative

D4 - the catalog number has been corrected to 02r28-32.

• Brand Name: ALINITY I HAVAB IGM REAGENT KIT
• Type of Device: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11144875
• MDR Text Key: 240107163
• Report Number: 3002809144-2021-00019
• Device Sequence Number: 1
• Product Code: LOL
• 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,Followup,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2021
• Device Catalogue Number: 02R28-32
• Device Lot Number: 18550BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI20013; ALNTY I PROCESSING MODU, 03R65-01, AI20013; ALNTY I PROCESSING MODU, 03R65-01, AI20013; ALNTY I PROCESSING MODU, 03R65-01, AI20013; ALNTY I PROCESSING MODU, 03R65-01, AI20013