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

Catalog Number	06L21-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
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.
Event or Problem Description
The customer observed falsely (b)(6) results while using architect (b)(6) reagents.The customer stated the specimen drawn on (b)(6) 2018 and tested on (b)(6) 2018 was initially (b)(6) and repeat using a diluted specimen (1:2 and 1:10) was (b)(6); however, no specific values were provided.Repeat of the specimen at another facility using the ortho vitros method was (b)(6), no specific values were provided.The patient was previously (b)(6) for (b)(6) on (b)(6) 2018 and (b)(6) 2018 when tested at another hospital using another method (ortho vitros).The (b)(6) 2018 specimen was also (b)(6) when tested by the state of (b)(6) and the (b)(6); however, the methods used and results values were not provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity determined that there was normal complaint activity for the likely cause lot 86118li00.Tracking and trending report review for the architect havab-m assay determined that there were no related adverse or non-statistical trends.The customer's returned samples (samples ids (b)(6) and (b)(6)) were tested with a retained kit of lot 86118li00 and non-reactive results of 0.48 and 0.56 s/co were generated.Both samples were then tested with biorad monolisa ha igm plus and vidas hav igm as reference tests and both assays generated positive results.To evaluate the performance of lot 86118li00, retained kits of the lot were tested in a sensitivity setup.All control values met specifications and were in the normal range.Additionally, a seroconversion panel was tested and the results were compared with historical performance provided by the panel manufacturer.Reagent lot 86118li00 detected the same first reactive bleed.Based on this data, the sensitivity performance is not adversely affected.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issues or deficiency was identified for the architect havab-m assay.

• 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: 7850698
• Report Number: 3002809144-2018-00302
• Device Sequence Number: 11385072
• Product Code: LOL
• UDI-Device Identifier: 00380740011093
• UDI-Public: 00380740011093
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/21/2019

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: 02/14/2019
• Device Catalogue Number: 06L21-25
• Device Lot Number: 86118LI00
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 02/21/2019
• 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 ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN (B)(4). ; LN 03M74-02 SN (B)(4). ; ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN (B)(4)