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

Catalog Number 1912997

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/27/2015

Event Type  malfunction  

Event Description

The customer complained after observing imprecise vitros tsh results for their vitros free thyroid control material on a vitros eciq immunodiagnostic system.Control level 3 results of 25.6, 12.9 and 12.1 miu/l vs expected 18.4 miu/l.As part of troubleshooting, within-run vitros tsh precision tests were performed by the customer using the vitros free thyroid control material and further breaches of the potential health and safety criteria were observed: control level 1 results of 0.076, 0.076, 0.079, 0.077, and 0.078 miu/l vs expected 0.058 miu/l.Biased patient results of the direction and magnitude observed may lead to inappropriate physician action.The customer provided no information to suggest patient samples were similarly affected; however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to occur undetected.There was no allegation of patient harm as a result of this event.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.(b)(4).

Manufacturer Narrative

The investigation determined that imprecise vitros tsh results were obtained for vitros free thyroid control material on a vitros eciq immunodiagnostic system.Root cause for the imprecise vitros tsh results above could not be determined, however the possibility that an unexpected vitros tsh reagent performances or unexpected analyzer performances had contributed to the results could not be ruled out.

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK
• 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: 4551458
• MDR Text Key: 21552648
• Report Number: 3007111389-2015-00047
• Device Sequence Number: 1
• Product Code: JLW
• 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
• Type of Report: Initial
• Report Date: 02/26/2015

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: 07/14/2015
• Device Catalogue Number: 1912997
• Device Lot Number: 4660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2014
• 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