MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-IGG; IGG ANTI-HAV

Catalog Number 06C29-27

Device Problem High Test Results (2457)

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

Event Date 04/04/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information, patient identifier = sid= (b)(4).There was no further patient information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6c29 that has a similar product distributed in the us, list number 6l27.

Event Description

The customer observed falsely elevated architect havab- igg results on a (b)(6) patient.The results were provided: on 04apr2020 sid (b)(4) initial havab igg result on frozen sample= 0.81 s/co (<1.0 s/co= nonreactive) / frozen specimen thawed and repeated on 06apr2020 havab igg results=1.34 s/co and 1.49 s/co(> or =1.00 s/co= reactive)/ other results direct bilirubin =5.0, ast =1000 and hepatitis a,b and c ,hepatitis b surface antibodies are positive.On 08apr2020 redraw and repeated new specimen havab-igg result=0.79 s/co (nonreactive).There was no reported impact to patient management.

Manufacturer Narrative

A review of the complaint records for architect havab igg lot number 09453be00 did not identify any problems related to false reactive results.Tracking and trending report review for the architect havab igg assay determined that there are no related adverse or non-statistical trends.Using worldwide field data, the performance of reagent lots 09453be00.The median and standard deviation to cutoff values of the negative population were within the established limits of the architect havab igg assay.Therefore, no unusual reagent performance was identified.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect havab igg, lot number 09453be00 assay was identified.

• Brand Name: ARCHITECT HAVAB-IGG
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9998113
• MDR Text Key: 189352417
• Report Number: 3002809144-2020-00341
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2020
• Device Catalogue Number: 06C29-27
• Device Lot Number: 09453BE00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 , SERIAL (B)(4).; LN 03M74-02 , SERIAL (B)(4).
• Patient Age: 1 YR