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

Catalog Number 1896836

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

The customer obtained non-reproducible vitros ck-mb quality control results (cliniqa l1= 5.07 vs.Expected 3.17 ng/ml) on a vitros 5600 integrated system.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.There was no report of affected vitros ck-mb patient sample results.There was no allegation of patient harm as a result of this event.(b)(4).

Manufacturer Narrative

The investigation determined that a higher than expected non-reproducible vitros ck-mb quality control result was obtained on a vitros 5600 integrated system.There was no evidence that a reagent issue or an instrument issue contributed to the event.The assignable cause of this event is unknown.However, pre-analytical quality control sample handling or atypical calibration, potentially related to the set of calibrators in use, could not be ruled out as contributing factors.

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS CK-MB 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: 4244122
• MDR Text Key: 4993122
• Report Number: 3007111389-2014-00248
• Device Sequence Number: 1
• Product Code: JHX
• 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: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2015
• Device Catalogue Number: 1896836
• Device Lot Number: 1690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2014
• 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