MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-G REAGENT KIT; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number 06C29-27

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/20/2021

Event Type  malfunction  

Manufacturer Narrative

Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer generated discrepant architect (b)(6) results for 1 patient while using lot 16137be00 in comparison to 20601be00.The following information was provided: sid (b)(4) initial result using lot 16137be00 0.52 s/co, repeated with lot 20601be00 5.67 s/co the customer is uncertain if the initial result is correct or the repeat result is correct.No impact to patient management was reported.

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

Component code: g01003 d8 was this device serviced by a third party? no a review of tickets was performed for reagent lot number 20601be00.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 architect havab igg reagent lot number 20601be00 was identified.

• Brand Name: ARCHITECT HAVAB-G 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: 11499912
• MDR Text Key: 266846530
• Report Number: 3002809144-2021-00171
• 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
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Catalogue Number: 06C29-27
• Device Lot Number: 20601BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR56731; ARC I1000SR MOD, 01L86-01, I1SR56731; ARC I1000SR MOD, 01L86-01, I1SR56731