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

Catalog Number 6801325

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/18/2014

Event Type  malfunction  

Event Description

A customer observed multiple discordant negative anti-hcv results obtained from a single non-vitros biorad virotrol reactive control sample using three different vitros ahcv lot 9090 reagent packs (pack id¿s 1159, 1161, and 1162) on 3 different vitros eciq immunodiagnostic systems.Pack 1159: 0.7888 s/c vs.Expected result >/ = 1.00 s/c.Pack 1161: 0.870, 0.735 s/c vs.Expected result >/ = 1.00 s/c.Pack 1162: 0.886, 0.895 s/c vs.Expected result >/ = 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 3500a forms are being submitted for this event as three devices were involved.(b)(4).

Manufacturer Narrative

The investigation concludes that discordant negative results were obtained from a single biorad virotrol reactive quality control fluid using three different vitros ahcv lot 9090 reagent packs (pack id¿s (b)(4) on 3 different vitros eciq immunodiagnostic systems.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.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• 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: 3988116
• MDR Text Key: 18293424
• Report Number: 3007111389-2014-00170
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/07/2014

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
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 08/07/2014
• 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
• Removal/Correction Number: TO FOLLOW
• Patient Sequence Number: 1