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

Catalog Number 06C29-22

Device Problem False Positive Result (1227)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

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, architect havab igg, list 6c29, that has a similar product distributed in the us, havab-g, list number 6l27.This event is also being reported in mfg reports 1628664-2019-00016 and 3002809144-2019-00007 for a second and third suspect device (list 03m74-02, serial (b)(4) and list 06c29-22, lots 92421li00, respectively).

Event Description

The customer reported multiple (b)(6) architect havab igg initial results of (b)(6).Repeat results were (b)(6).Through troubleshooting many 3350 (aspiration errors) for sample pipettor were found.Gel was also found in the sample probe.However, after troubleshooting results that had become nonreactive, again became reactive.The following sid with results were provided: sample (b)(6): (b)(6).Sample (b)(6): (b)(6).Sample (b)(6): (b)(6).Sample (b)(6): (b)(6).No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, similar complaints, tracking and trending data, statistical performance, field data, and product labeling.Ticket searches determined that there is a trend in complaint activity for lot number 92421li00/92425li00 regarding false reactive patient results.During the 12 months tracking and trending review adverse and non-statistical trends were identified for the complaint issue during the reviewed timeframe.The present ticket is related to the non-statistical trends but not related to the adverse trend for arch havab igg assay, ln 6c29.When evaluating performance with regard to specificity, the generated data do not indicate that the reagent is compromised.A review of field data indicated that the lot number is performing in line with all other reagent lots in the field during the reviewed timeframe.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.This event was previously submitted under two additional manufacturer report numbers, for two other likely causes, which were manufacturer report number 1628664-2019-00016 (ln 03m74-02) and manufacturer report number 3002809144-2019-00007 (ln 06c29-22, lot 94521li00).All further information will be documented under the manufacturer report number for this mdr (3002809144-2019-00006).

• Brand Name: ARCHITECT HAVAB-IGG
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8229428
• MDR Text Key: 132922691
• Report Number: 3002809144-2019-00006
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2019
• Device Catalogue Number: 06C29-22
• Device Lot Number: 92421LI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-02; ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4); SERIAL (B)(4)