MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C702

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received a questionable bilt3 bilirubin total gen.3 result for one patient sample.The initial result was 9.6 mg/dl.The repeat result with a 1:3 dilution was 13.47 mg/dl.The erroneous initial result was reported outside the laboratory.The repeat result was believed to be correct.There was no adverse event.The reagent lot number was 18673301 with an expiration date of 04/30/2018.The field service representative found the gear pump pressure was low which he adjusted to specification.He performed checks of the probe alignments, the rinse tubings, and cuvette water levels which were ok.He ran a mechanism check with no problem found.He ran precision testing and results were all within specification.The customer ran qc and verified results were within their specification.A query found no past or new complaints of this nature on a like instrument at this site during the past 12 months.No abnormal trend identified with the pump head assembly.

• Brand Name: COBAS 8000 C 702 MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6601392
• MDR Text Key: 76317440
• Report Number: 1823260-2017-01115
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C702
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 DA