MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ARCHITECT TOTAL B-HCG

Catalog Number 07K78-74

Device Problem False Positive Result (1227)

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

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false positive architect total bhcg results on one (b)(6) female patient.The results provided were: on (b)(6) 2020 initial bhcg result=935.97 miu/ml (>or=25.00 miu/ml=positive)/repeated result=<1.2 miu/ml (

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, troubleshooting, a search for similar complaints, instrument service history review, and a review of product labeling.A review of tickets was performed for architect total b-hcg reagent lot number 08042ui01.The ticket search found no complaints similar to this issue.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.Historical performance of the architect total b-hcg assay was evaluated using world wide data from abbottlink.The patient median result for the lot is comparable with other lots in the field and confirms no systemic issue for the lot.A retained reagent kit of lot number 08042ui01 was tested in a sensitivity setup and results of this setup did not implicate that the performance of the lot was negatively impacted.All specifications were met indicating the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.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 total b-hcg assay lot number 08042ui01 was identified.

• Brand Name: ARCHITECT TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; longford na, irl; co. longford; lisnamuck N39E9
• MDR Report Key: 10315740
• MDR Text Key: 203116996
• Report Number: 3005094123-2020-00157
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Catalogue Number: 07K78-74
• Device Lot Number: 08042UI01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR INTGR, 01L86-40, (B)(6) ; ARCHITECT I1000SR ANALYZER; LIST # 01L86-40, SERIAL # (B)(6)
• Patient Age: 22 YR