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

Catalog Number 6801042

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

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

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that lower than expected myoglobin results were obtained from a non-vitros quality control fluid using vitros immunodiagnostics products myoglobin reagent pack lot 1220 on a vitros 5600 integrated system (b)(4).The assignable cause is attributed to user error associated with an unknown maintenance issue as the qc shift low occurred after the customer performed maintenance actions on the vitros 5600 integrated system.The same biorad qc fluid was run on the customers alternative analyzer without experiencing the same shift.A review of the historical qc results for vitros myoglobin indicates performance was acceptable prior to and up to the date of the maintenance, and therefore vitros myoglobin lot 1220 performance issue is not a likely contributor to the event.The customer repeated the maintenance actions of cleaning the microwell incubator, the signal reagent probe, the well wash probe, and replacing the vapor adsorption cartridge and subsequent qc results were acceptable.

Event Description

The customer observed lower than expected myoglobin results obtained from a non-vitros quality control (qc) fluid using vitros immunodiagnostic products myoglobin reagent pack on a vitros 5600 integrated system.Biorad level 1 lot 23636 results: 84.36, 82.65, 85.52, 88.75, and 84.44 ng/ml versus customer baseline mean 131 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected and the event were to recur undetected.There was no allegation of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN 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: 6797104
• MDR Text Key: 85782166
• Report Number: 3007111389-2017-00125
• Device Sequence Number: 1
• Product Code: DDR
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2018
• Device Catalogue Number: 6801042
• Device Lot Number: 1220
• Other Device ID Number: 10758750001019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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