COBAS 8000 C 702 MODULE C702 06473245001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-16 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.

Event Text Entries

[93373274] (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[93373275] The customer initially complained of erroneous high results for 2 patient samples tested for albumin on a cobas 8000 c 702 module. Patient 1 initial albumin result was 104. 5 g/l. The sample was repeated on another instrument in the laboratory and the result was 44. 1 g/l. Patient 2 initial albumin result was 73. 1 g/l. The sample was repeated on another instrument in the laboratory and the result was 40. 7 g/l. It is not known if the erroneous results for these 2 patient samples were reported outside of the laboratory. The customer provided additional results for 16 patient samples that were tested for albumin, creatinine, urea or uric acid. Based on the data provided, the results for 7 patient samples were erroneous when tested for albumin, uric acid or creatinine. The erroneous result for 1 patient tested for creatinine was reported outside of the laboratory and corrected following the repeat test. There was no allegation that an adverse event occurred. No reagent lot numbers or expiration dates were provided. The field service engineer (fse) visited the customer site on 03-nov-2017 and found a dripping cell cleaner nozzle on one of the rinse units. The nozzle and tubing was flushed and the one-way valve was checked and replaced. During a review of the reaction monitor, an issue was observed that appears to be carryover or dripping into the cuvette. This corresponds to the fse finding of the dripping cleaner nozzle.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2017-02632
• MDR Report Key: 7037717
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2017-11-16
• Date of Report: 2017-12-06
• Date of Event: 2017-10-23
• Date Mfgr Received: 2017-10-26
• Date Added to Maude: 2017-11-16
• 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 C 702 MODULE
• Generic Name: CLINICAL CHEMISTRY ANALYZER
• Product Code: CJW
• Date Received: 2017-11-16
• Model Number: C702
• Catalog Number: 06473245001
• 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 462500457 US 462500457

Device Sequence Number: 1

• Brand Name: COBAS 8000 C 702 MODULE
• Generic Name: CLINICAL CHEMISTRY ANALYZER
• Product Code: JJE
• Date Received: 2017-11-16
• Model Number: C702
• Catalog Number: 06473245001
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• 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 462500457 US 462500457

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-11-16