MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CKMB SLIDES; IN-VITRO DIAGNOSTIC

Catalog Number 8001133

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

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

Event Date 12/11/2014

Event Type  malfunction  

Event Description

The customer reported that a lower than expected vitros ckmb result was obtained from one proficiency sample when tested on a vitros 5,1fs chemistry system using vitros ckmb microslide reagent.Sample cm-01 vitros ckmb result: 15.00 u/l vs.Expected 21.36 u/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action.No patient samples were affected; however, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of this event.(b)(4).

Manufacturer Narrative

The investigation determined that a lower than expected vitros ckmb result was obtained from one proficiency sample when tested on a vitros 5,1fs chemistry system using vitros ckmb microslide reagent.The definitive assignable cause could not be determined.The investigation found that a potential vitros ckmb reagent issue and/or improper pre-analytical sample handling (sample stored past the sample stability recommendations) cannot be ruled out as contributing factors.The investigation demonstrated that the vitros 5,1chemistry system was operating as expected at the time of the event.

• Brand Name: VITROS CHEMISTRY PRODUCTS CKMB SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 4403804
• MDR Text Key: 18544258
• Report Number: 1319809-2015-00001
• Device Sequence Number: 1
• Product Code: JHS
• 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: 01/09/2015

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: 06/01/2016
• Device Catalogue Number: 8001133
• Device Lot Number: 4932-0199-8605
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2014
• 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