C502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-20 for C502 manufactured by Roche Diagnostics.

Event Text Entries

[50770735] This mdr is being reported under (b)(4) and is part of the 227 pilot program. The reported event involved an automated clinical chemistry device which is serviced in the field and not routinely returned for investigation. This device is not labeled for single use and is not reprocessed or reused. As this event occurred outside of the united states, information regarding a field representative visit was not provided. Further investigation by the manufacturer did not identify a specific root cause for the event. A general reagent issue was not likely as calibration and qc was acceptable. Possible causes include a sample delivery, processing, and storage condition issue. No systemic issue with the device was identified during the investigation of this event.
Patient Sequence No: 1, Text Type: N, H10

[50770736] This report summarizes 1 malfunction event where erroneous results were generated by the cobas c502 analyzer. There were erroneous results for ethanol gen. 2 for six patients. The patients' ages, genders, and weights were requested, but were not provided. There was no reported injury or death. The event did not necessitate remedial action to prevent an unreasonable risk of substantial harm to public health.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2016-01016
• MDR Report Key: 5809504
• Date Received: 2016-07-20
• Date of Report: 2016-07-20
• Date of Event: 2015-12-31
• Date Mfgr Received: 2016-05-23
• Date Added to Maude: 2016-07-20
• 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: 0

Device Sequence Number: 0

• Brand Name: NA
• Generic Name: CLINICAL CHEMISTRY ANALYZER
• Product Code: DIC
• Date Received: 2016-07-20
• Model Number: C502
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: NA NA INDIANAPOLIS IN US

Device Sequence Number: 1

• Brand Name: NA
• Generic Name: CLINICAL CHEMISTRY ANALYZER
• Product Code: JJE
• Date Received: 2016-07-20
• Model Number: C502
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: NA NA INDIANAPOLIS IN US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-07-20