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

Catalog Number	06L21-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information: no specific patient information was provided.
Event or Problem Description
The customer reported imprecise and a (b)(6) result for one patient.The patient's samples (sample ids (b)(6)) generated one (b)(6) result of (b)(6) and multiple (b)(6) results ranging from (b)(6) to (b)(6).No impact to patient management was reported.
Additional Manufacturer Narrative
Ticket searches determined that there was normal complaint activity for complaint lot 91529li00.Tracking and trending report review for the architect havab-m assay determined that there were no related trends.Retained reagent kits of lot 91529li00 were tested in a sensitivity setup including additional replicates of positive control.The reagent lot showed normal performance and no false non-reactive results were obtained.Additionally, the clinical sensitivity of the reagent lot was evaluated by testing a commercially available seroconversion panel.The results were compared to the architect havab-m test results provided by the panel manufacturer.Reagent lot 91529li00 detected the same first reactive bleed with comparable s/co values.Based on this data it was shown that the sensitivity performance is not adversely affected.Manufacturing documentation for the 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-m, reagent lot 91529li00 was identified.

• Brand Name: ARCHITECT HAVAB-M
• Common Device Name: IGM ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8396199
• Report Number: 3002809144-2019-00090
• Device Sequence Number: 2926614
• Product Code: LOL
• UDI-Device Identifier: 00380740011093
• UDI-Public: 00380740011093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063329
• 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): 08/21/2019

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: 07/20/2019
• Device Catalogue Number: 06L21-25
• Device Lot Number: 91529LI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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)(4); SERIAL (B)(4)