MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV REAGENT KIT; ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS

Model Number	1L79-35
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This event was previously reported through 3002809144-2021-00238-01; however on 29 apr 2021 it was identified that an additional reagent lot was involved in this event.
Event or Problem Description
The customer generated falsely (b)(6) architect (b)(6) results for 2 patients.The following information was provided: sid (b)(6) initial result (b)(6).The customer reported this patient as (b)(6).Sid (b)(6) initial result (b)(6) (grayzone), repeat (b)(6) the customer reported this patient as (b)(6).No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from architect anti-hcv reagent kit, list number 01l79-35 lot 25575be00, manufactured in wiesbaden, germany in section d of this report to architect anti-hcv reagent kit, list number 01l79-35 lot 21461be00, manufactured in wiesbaden, germany.Mdr number 3002809144-2021-00238 has been submitted and all further information will be documented under that mdr number.This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: ARCHITECT ANTI-HCV REAGENT KIT
• Common Device Name: ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11824991
• Report Number: 3002809144-2021-00315
• Device Sequence Number: 1153726
• Product Code: MZO
• UDI-Device Identifier: 00380740001421
• UDI-Public: 00380740001421
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P050042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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 Model Number: 1L79-35
• Device Catalogue Number: 01L79-35
• Device Lot Number: 25575BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)