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

Model Number	6L27-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account stated false reactive architect havab-g results were generated on samples that had anti-hcv high viral loads.Architect havab-g reactive values of 1.73 to 3.5 s/co were generated on samples that tested siemens centaur havab total negative.No specific patient information or data will be provided.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined there is normal complaint activity for lot number 03429be00 for tickets with false reactive results above the determined s/co range of 1.00 - 1.72 s/co.A review of the tracking and trending report determined there are no trends for the complaint issue.Field data for the architect havab-g reagent was used to review the median of a negative population and population by lot number.Lot 03429be00 showed a median result within the established limits for both populations.Additionally, the number of standard deviations to the cut-off for the negative population were evaluated and it was noted that the number of standard deviations to the cut-off for lot 03429be00 was within the established limits.Manufacturing documentation associated with the reagent lot was reviewed.This review did identify a nonconformance as the lot was manufactured with impacted material, however the results generated by the customer were not impacted.Labeling was reviewed and sufficiently addresses the customer issue.Based on the investigation, no systemic issue or product deficiency was identified for the architect havab-g reagent, lot 03429be00.

• Brand Name: ARCHITECT HAVAB-G
• Common Device Name: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9927092
• Report Number: 3002809144-2020-00299
• Device Sequence Number: 2818049
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2020
• Device Model Number: 6L27-25
• Device Catalogue Number: 06L27-25
• Device Lot Number: 03429BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/05/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR LIST 03M74-02.; ARCHITECT I2000SR LIST 03M74-02.; SERIAL (B)(6). ; SERIAL (B)(6). ; ARCHITECT I2000SR LIST 03M74-02; SERIAL (B)(4).