MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS; CLINICAL CHEMISTRY ANALYZER

Catalog Number 03245233997

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Initial reporter.- an e-mail address of (b)(6) was also provided.

Event Description

The customer reported that they received erroneous results for one patient sample tested for creatinine jaffe gen.2 - compensated method for serum and plasma (crea).The results from an integra 400 plus analyzer, a c501 analyzer, and an analyzer from a different site did not compare.The sample initially resulted as 1.11 mg/dl on an integra 400 plus and this result was reported outside of the laboratory to the patient.The sample was repeated on the same analyzer, resulting as 1.17 mg/dl.The sample was then repeated a second time on a c501 analyzer, resulting as 1.64 mg/dl accompanied by a data flag.The sample was repeated a third time on the integra 400 plus analyzer, resulting as 1.10 mg/dl.The sample was repeated a fourth time in another laboratory, resulting as 1.6 mg/dl.The model and serial number of the analyzer used at the other site were asked for, but not provided.It was noted that the results for other tests from the patient were not affected.The patient was not adversely affected.The crea reagent lot number was 6110320, with an expiration date of 10/30/2016.

Manufacturer Narrative

The customer believed that the result generated by the c501 analyzer was correct and that the results generated by the integra 400 plus analyzer were incorrect.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.Investigations have determined that it seems that the integra 400 plus results are correct.

• Brand Name: COBAS INTEGRA 400 PLUS
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5019214
• MDR Text Key: 23667411
• Report Number: 1823260-2015-04002
• Device Sequence Number: 0
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03245233997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 07/27/2015
• 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: 049 YR