MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATINE KINASE; DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES

Catalog Number 04524977190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable creatine kinase results for one patient sample from two cobas c501 analyzers.The initial result from cobas c501 serial number (b)(4) was 692.6 u/l with a data flag.The repeat testing gave no numeric result but a data flag.The sample was repeated on cobas c501 serial number (b)(4) and the result was 296.4 u/l which was reported outside the laboratory.Later in the day, a repeat sample was received for the patient and the customer decided to repeat the original sample.The sample was repeated on cobas c501 serial number (b)(4) and the results were 341 u/l with a data flag and no numeric result but a data flag.The sample was repeated on cobas c501 serial number (b)(4) and the results were 485.3 u/l with a data flag and no numeric result but a data flag.With a 1:20 dilution, the results in sample cups were 35748 u/l and 29164 u/l.The results with the dilution were believed to be correct and a corrected report was issued.The patient was not adversely affected.

Manufacturer Narrative

A specific root cause could not be identified.Based on the provided calibration, qc, and precision data, the instruments were working according to specifications.As only one sample was affected, the issue seems to be a preanalytic sample issue.

• Brand Name: CREATINE KINASE
• Type of Device: DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5160115
• MDR Text Key: 28675583
• Report Number: 1823260-2015-04354
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 12/16/2015

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 Catalogue Number: 04524977190
• Device Lot Number: 66033801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 051 YR