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 Consequences Or Impact To Patient (2199)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

The customer reported lower and higher than expected vitros tsh quality control results obtained using vitros free thyroid control on a vitros 5600 integrated system.Level 1 result: 0.32 miu/l vs.Expected 0.050 miu/l; level 2 result: 0.99 miu/l vs.Expected 1.42 miu/l; level 3 result: 9.039 miu/l vs.Expected 19.1 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action.The customer had discontinued processing routine vitros tsh testing until acceptable quality control results post calibration were obtained; 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.(b)(4).

Manufacturer Narrative

The investigation confirmed that lower and higher than expected vitros tsh quality control results were obtained using vitros free thyroid control on a vitros 5600 integrated system.A definitive root cause for the event could not be determined; however, the possibility that inappropriate pre-analytical sample processing, a vitros tsh reagent issue or an unexpected vitros 5600 system malfunction had contributed to the events 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: 4608662
• MDR Text Key: 5633578
• Report Number: 3007111389-2015-00062
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2015

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: 11/05/2015
• Device Catalogue Number: 1912997
• Device Lot Number: 4730
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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