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

Catalog Number 03245233001

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received high results for one patient sample tested for tina-quant d-dimer gen.2 (ddi).The doctor ordered a ddi test on the patient based on the patient's symptoms.The sample initially resulted as 0.99 ugfeu/ml and this value was reported outside of the laboratory as 1.0 ugfeu/ml.The patient went to the hospital 3 to 4 hours later and a new sample was collected.The new sample resulted as 0.25 ugfeu/ml.The original sample was repeated on (b)(6) 2015 and resulted as 0.99 ugfeu/ml.The patient was not adversely affected.The ddi reagent lot number and expiration date were asked for, but not provided.

Manufacturer Narrative

The new sample which resulted as 0.25 ugfeu/ml was tested on a c501 analyzer.This same sample was repeated on (b)(6) 2015, resulting as 0.24 ugfeu/ml.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.Due to the extreme differences in the values, a sample mix-up could not be excluded as a root cause.

• 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: 4844939
• MDR Text Key: 22379525
• Report Number: 1823260-2015-03631
• Device Sequence Number: 0
• Product Code: GHH
• 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,User Facility,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03245233001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 051 YR