MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT; IN-VITRO DIAGNOSTIC

Catalog Number 6801325

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

A customer observed multiple (b)(4) results obtained from a single non-vitros biorad virotrol reactive control sample using three different vitros ahcv lot 9090 reagent packs (pack 1510, pack 1543, unidentified pack) on two different vitros eciq immunodiagnostic systems and a single vitros 3600 immunodiagnostic system.Pack 1510: (b)(4) vs.The expected result of >/ = 1.00 s/c.Pack 1543: (b)(4) vs.The expected result of >/ = 1.00 s/c.Unidentified pack: (b)(4) vs.The expected result of >/ = 1.00 s/c.There was no report of affected patient samples, however; the investigation cannot conclude that patient sample results had not been affected or would not be affected if the event were to recur undetected.There were no allegations of harm as a result of this event.This report is number one of three mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as 3 devices were involved.(b)(4).

Manufacturer Narrative

The investigation concludes that (b)(6) results were obtained from a single biorad virotrol reactive quality control fluid using three different vitros ahcv lot 9090 reagent packs on two different vitros eciq immunodiagnostic systems and a single vitros 3600 immunodiagnostic system.The assignable cause for the event is the vitros ahcv lot 9090 reagent packs in use.Multiple vitros ahcv lot 9090 reagent packs in use at multiple sites are producing lower than expected results.The assignable cause affecting the lot 9090 reagent packs is unknown.The investigation is ongoing.There was no indication the vitros instruments contributed to the event.Please refer to report # 3007111389-08/13/2014-001-c.

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 4012540
• MDR Text Key: 4688138
• Report Number: 3007111389-2014-00179
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/15/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2014
• Device Catalogue Number: 6801325
• Device Lot Number: 9090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1