MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable ca2 calcium gen.2 results for two patient samples.Of the data provided, only the erroneous result for one patient sample was reported outside the laboratory.The initial result was 5.7 mg/dl and was reported outside the laboratory.The doctor sent the patient to the emergency room (er) and a new sample was drawn with a result of 10.1 mg/dl.The original sample was repeated on (b)(6) 2017 and the result was 9.9 mg/dl.The repeat result was considered correct.The sample was also tested on the integra 400 and the result matched the repeat result.No specific data from the integra 400 was provided.The customer did not know of any treatment provided based on the erroneous result and the patient was discharged from er.No adverse event was reported.The reagent lot number was 22326401 with an expiration date of 5/31/2018.The field service representative found an issue with the sample probe.He adjusted the internal sample probe pressures, replaced the vacuum line on the rinse mechanism, adjusted the gear pump head, and checked the pressure.The customer ran qc which passed within their specifications.The field application specialist did not find an issue with the application.He checked the application settings, had the customer add their critical range repeat values, and verified calibration and qc had been acceptable.He verified no other assays showed performance problems.Upon follow up, the customer confirmed there were no further issues after the service visit.Based on review of the provided calibration and qc data, a general reagent issue was excluded.

• Brand Name: COBAS 6000 C501 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: 6631042
• MDR Text Key: 77619596
• Report Number: 1823260-2017-01202
• Device Sequence Number: 0
• Product Code: CIC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• 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: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• 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: 73 YR
• Patient Weight: 83