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

Catalog Number 06C30-27

Device Problem False Negative Result (1225)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 reported (b)(6) architect havab-igm result for a patient.The following data was provided (reference range: < 0.80 s/co = nonreactive, 0.80 to 1.20 s/co = grayzone (gz), > 1.20 s/co = reactive): (b)(6).There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false non-reactive results for two samples of the same patient 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 a retained kit of the complaint lot number.Return testing was not completed as returns were not available.A ticket search by lot indicates the reagent lot performs as expected for this product.Trending review determined no trends identified for the issue for the product.The device history record review did not identify any non-conformances or deviations associated with the complaint issue.Testing of a retained reagent kit of the complaint lot number 21415be00 determined that the sensitivity performance was not negatively impacted.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency with the architect havab igm reagent lot 21415be00 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: 11679601
• MDR Text Key: 268056163
• Report Number: 3002809144-2021-00257
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Catalogue Number: 06C30-27
• Device Lot Number: 21415BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR RECONDIT KO, 03M74-65, (B)(4); ARC I2000SR RECONDIT KO, 03M74-65, (B)(4)