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

Catalog Number 1912997

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

The customer obtained discrepant vitros tsh result on a single patient sample tested on two different vitros systems; a vitros eci immunodiagnostic system and a vitros 5600 integrated system.These results were obtained using two different lots of vitros tsh reagent.Vitros tsh results 0.185; 0.632 and 0.744 vs.Expected 0.472 miu/l.Biased results of the direction and magnitude observed could lead to inappropriate physician action.The discrepant patient sample results were not reported outside of the laboratory and there was no allegation of patient harm as a result of this event.This report is number two 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 discordant vitros tsh patient results obtained from a single patient sample were observed when processed with two different vitros systems using two different vitros tsh reagent lots.The event was isolated to multiple testing events of a single patient sample and based on the information provided there was no evidence a vitros tsh reagent or instrument issue contributed to the event.A sample related issue or improper pre-analytical sample processing cannot be ruled out as a potential contributing factors for the event as the sample in question was centrifuged outside the sample collection device manufacturer¿s recommended protocol.The investigation was unable to determine a definitive root cause.

• Brand Name: VITROS IMMUNODIAGNOSTIC 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: 4097224
• MDR Text Key: 21493181
• Report Number: 3007111389-2014-00211
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 09/17/2014

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: Medical Technologist
• Device Expiration Date: 01/30/2015
• Device Catalogue Number: 1912997
• Device Lot Number: 4530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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