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 Type  malfunction  

Manufacturer Narrative

Complete patient identifiers: (b)(6).All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false reactive (b)(6) igg results for two patients, when processing on the architect i2000sr.The following data was provided: sid (b)(6): isr52410 initial: 3.25 s/co.Isr51772 retest: 0.69 s/co.Isr52410 retest: 1.13 s/co.Retest with isr52410 at a later date: 0.91 s/co.Sid (b)(6): isr52410 initial: 4.40 s/co.Isr51772 retest: 0.82 s/co.Isr52410 retest: 2.40 s/co.Retest with isr52410 at a later date: 0.37 s/co.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined there is slightly elevated complaint activity for the architect havab igg reagent, lot number 03402be00.Tracking and trending report review did not identify any related trends.A review of field data for the architect havab igg reagent was performed as well as a review of the performance for the likely cause lot, 03402be00.The review showed that the median and standard deviations to the cutoff of the negative population for the likely cause lot were within established baselines; therefore, the performance of lot 03402be00 was not found to be compromised.Manufacturing documentation was reviewed and no issues were identified.Additionally, labeling was reviewed and sufficiently addresses the customers issue.Based on the investigation, no systemic issue or product deficiency of the architect havab igg reagent was identified.Correction to section d11: concomitant medical products and therapy dates: serial corrected from 03m74-01 to (b)(4).

• 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: 9280118
• MDR Text Key: 219780474
• Report Number: 3002809144-2019-00811
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2020
• Device Catalogue Number: 06C29-22
• Device Lot Number: 03402BE00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-01; ARCHITECT I2000SR, LIST 03M74-01; SERIAL (B)(4); SERIAL (B)(4)