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

Catalog Number 06C30-74

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number (b)(4), that has a similar product distributed in the us, list number (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer stated that a (b)(6) architect (b)(6) result of 0.47 s/co was generated for a patient sample (<0.80 s/co is negative).The sample was weakly positive using an elisa method (not specified).A new sample was collected from the patient and the architect (b)(6) result was 0.39 s/co.No adverse impact to patient management was reported.

Manufacturer Narrative

No customer returns were available.The complaint investigation for false non-reactive results for one sample tested with the architect havab igm assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and testing of retained kits with the complaint lot numbers.Trending review determined no adverse trend for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Inhouse testing of retained kits of the complaint lot numbers determined that the sensitivity performance is not negatively impacted.Based on the investigation, no systemic issue or deficiency with the architect havab igm reagent lot was identified.

• Brand Name: ARCHITECT HAVAB-M 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: 10861892
• MDR Text Key: 240116791
• Report Number: 3002809144-2020-01122
• 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
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Catalogue Number: 06C30-74
• Device Lot Number: 12568BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR60536; ARC I2000SR INST, 03M74-02, ISR60536