COBAS INTEGRA 400 PLUS 03245233001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-06-18 for COBAS INTEGRA 400 PLUS 03245233001 manufactured by Roche Diagnostics.

Event Text Entries

[1259200] The user experienced the calcium qc drifting lower since (b) (6) 2009 and received discrepant calcium results on (b) (6) 2009 for two patient samples in lithium heparin tubes. Patient 1 original result was 8. 0 mg per dl and was reported. The user repeated the sample with results of 8. 1 and 8. 0 mg per dl. After the user changed to a new lot number of reagent the sample was repeated the same day and a corrected report of 9. 1 mg per dl was sent out. Patient 2 original result was 7. 8 mg per dl and was reported. The user repeated the sample with a result of 7. 9 mg per dl twice. After the user changed to a new lot number of reagent the sample was repeated the same day and a corrected report of 8. 8 mg per dl was sent out. The user stated these 2 patients are receiving infusion therapy for osteoporosis. As a result of the original calcium result for patient 2, the patient did not receive the infusion at that time because they believed her calcium level to be too low. The user stated that patient is to come back in for a repeat calcium test and that time will be evaluated regarding getting an infusion. The user stated this patient also had a low vitamin d level which also precluded her from having the infusion so the user did not consider the low calcium value as the only reason she did not have the infusion. The user did not consider this calcium result to have an adverse affect on the patient. The user stated since utilizing the new lot number of reagent, she does not believe she has had any further problems with patient results. The field service representative agreed the reagent was the cause and performed check tests on the analyzer to verify performance.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2009-04278
• MDR Report Key: 1461839
• Report Source: 05,06
• Date Received: 2009-06-18
• Date of Report: 2009-06-18
• Date of Event: 2009-05-27
• Date Facility Aware: 2009-05-28
• Report Date: 2009-05-28
• Date Mfgr Received: 2009-05-28
• Date Added to Maude: 2010-03-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: MEDICAL TECHNOLOGIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 3
• Manufacturer Contact: ERIC KOLODZIEJ
• Manufacturer Street: 9115 HAGUE RD.
• Manufacturer City: INDIANAPOLIS IN 46250
• Manufacturer Country: US
• Manufacturer Postal: 46250
• Manufacturer Phone: 3175212834
• Manufacturer G1: ROCHE INSTRUMENT CETNER AG
• Manufacturer Street: FORRENSTRASSE TEGIMENTA
• Manufacturer City: ROTKREUZ
• Manufacturer Country: SZ
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COBAS INTEGRA 400 PLUS
• Generic Name: CLINICAL CHEMISTRY ANALYZER - JJE
• Product Code: JFP
• Date Received: 2009-06-18
• Catalog Number: 03245233001
• Operator: OTHER
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: INDIANAPOLIS IN US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-06-18