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

Model Number 7K78-25

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided.

Event Description

The customer stated that a false positive architect total bhcg result of 431.74 iu/l was generated for a patient (sid (b)(6)) on (b)(6) 2020 and was questioned by the physician.The same sample retested negative at <1.2 iu/l.No adverse impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false positive results for one patient when tested with the architect total b-hcg assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labelling review, device history record review, field data review and inhouse testing of retained kits with the complaint lot number.Trending review determined no adverse trend for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot.Inhouse testing determined that the specificity performance is not negatively impacted.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance of the lot is acceptable.Based on our investigation, we have determined that there is no general issue with the architect total b-hcg reagent lot identified in this complaint.

• Brand Name: ARCHITECT TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 10286024
• MDR Text Key: 203328954
• Report Number: 3005094123-2020-00149
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: 00380740014964
• Combination Product (y/n): N
• PMA/PMN Number: K983424
• 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: 09/16/2020

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: 07/16/2020
• Device Model Number: 7K78-25
• Device Catalogue Number: 07K78-25
• Device Lot Number: 06106UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST 03M74-02; ARCHITECT I2000SR ANALYZER, LIST 03M74-02; SERIAL (B)(4); SERIAL (B)(4)