COBAS 8000 C502 MODULE 05964067001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-10-28 for COBAS 8000 C502 MODULE 05964067001 manufactured by Roche Diagnostics.

Event Text Entries

[29410086]
Patient Sequence No: 1, Text Type: N, H10

[29410087] The customer received questionable benzodiazepine plus results for two patient urine samples. Both patient results were positive on an initial quick screen (unknown method), but were negative when run on the cobas c502 analyzer. The samples were sent out for gcms testing and the result for patient 1 was >4000 ng/ml. The gcms result for patient 2 was 3295 ng/ml. Patient 2 was retested on the cobas c502 and the result was negative. The specific date of testing was not provided. Patient 2 was initially tested on (b)(6) 2015. The patient was an (b)(6) male. The initial negative results were reported outside the laboratory. The results by gcms were believed to be correct. The patients were not adversely affected. The reagent lot number was 60724801. The expiration date was requested, but was not provided. The field service representative could not find a cause. He checked the cell rinse, probe rinsing, and probe alignment. He adjusted the gear pump pressure as it was a little low. He repeated one of the samples that originally tested negative and the results was still negative. He successfully ran a precision check.
Patient Sequence No: 1, Text Type: D, B5

[30883546] The investigation found the assay performed according to specification. The patients were taking temezepam which is very often present in urine in form of temazepan glucuronide and therefore not detectable by the benzodiazepine assay without treatment with glucorinidase.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1823260-2015-04403
• MDR Report Key: 5183066
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2015-10-28
• Date of Report: 2015-11-10
• Date of Event: 2015-09-25
• Date Mfgr Received: 2015-10-08
• Date Added to Maude: 2015-10-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: NA MICHAEL LESLIE
• Manufacturer Street: 9115 HAGUE ROAD NA
• Manufacturer City: INDIANAPOLIS IN 46250
• Manufacturer Country: US
• Manufacturer Postal: 46250
• Manufacturer Phone: 3175214343
• Manufacturer G1: HITACHI HIGH TECH CORP.
• Manufacturer Street: 882 ICHIGE HITACHINAKA NA
• Manufacturer City: IBARAKI 312-8504
• Manufacturer Country: JA
• Manufacturer Postal Code: 312-8504
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: COBAS 8000 C502 MODULE
• Generic Name: CLINICAL CHEMISTRY ANALYZER
• Product Code: NFV
• Date Received: 2015-10-28
• Model Number: NA
• Catalog Number: 05964067001
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250

Device Sequence Number: 1

• Brand Name: COBAS 8000 C502 MODULE
• Generic Name: CLINICAL CHEMISTRY ANALYZER
• Product Code: JJE
• Date Received: 2015-10-28
• Model Number: NA
• Catalog Number: 05964067001
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-10-28