MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT ANTI-HBS

Catalog Number 07C18-29

Device Problem False Positive Result (1227)

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

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: complete entry = (b)(6).Patient information: no further information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer obtained a (b)(6) architect (b)(6) result for a (b)(6) female patient.Sample id (b)(6) generated 13.31 miu/ml for (b)(6) and also generated a (b)(6) result (126.62 iu/ml) for (b)(6).The patient has a history of being (b)(6) for both (b)(6) (67.54 to >250 iu/ml) and (b)(6) (12.14 to 18.5 miu/ml).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a search for similar complaints, and review of complaint text, trending data, labelling, and device history records.Return testing was not completed as returns were not available.A review of complaint activity determined that there was normal complaint activity for reagent lot 06340fn00.The overall performance of reagent lot 06340fn00 was evaluated using worldwide field data and indicated that the performance of the lot is acceptable.Review of tracking and trending reports did not identify any related trends for the architect anti-hbs assay.Device history record review on lot 06340fn00 did not identify any issues.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs assay, lot number 06340fn00 was identified.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10148003
• MDR Text Key: 199450505
• Report Number: 3008344661-2020-00044
• Device Sequence Number: 1
• Product Code: LOM
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• Device Catalogue Number: 07C18-29
• Device Lot Number: 06340FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-01,; ARCHITECT I2000SR, LIST 03M74-01,; SERIAL (B)(6) ; SERIAL (B)(6)
• Patient Age: 67 YR