MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C513 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C513

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of erroneous high results for 3 patient samples tested for tina-quant hemoglobin a1cdx gen.3 (a1cx3) on a cobas c 513 analyzer.The erroneous results were reported outside of the laboratory.Patient 1 initial a1cx3 result from the c513 analyzer was 22.94%.The sample was repeated on the same analyzer and the result was 5.18%.Patient 2 (male with date of birth (b)(6)) initial a1cx3 result on the c513 analyzer was 21.21%.The sample was repeated on a different c513 analyzer and the result was 6.78%.The sample was repeated on the c513 analyzer in question and the result was 6.75%.Patient 3 initial a1cx3 result was 15.97%.The sample was repeated on the different c513 analyzer and the result was 5.54%.No adverse event occurred.The a1cx3 reagent lot number was 223184.The expiration date was not provided.A cell blank error occurred and the customer replaced the cuvettes.The customer found that one cell segment was not adjusted properly and the probe may have been scratching the cuvette.After the customer adjusted the cell segments correctly, the a1cx3 results were plausible.The customer replaced the closed tube sampling (cts) probe.The field service representative (fsr) visited the customer site and found that the wash needle did get stuck at the misadjusted cuvette segment and scratched the corner of the cuvette.After replacing the cuvette and the probe, no further issues occurred.The system was operating within specification.

• Brand Name: COBAS C513 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: 6882299
• MDR Text Key: 89313563
• Report Number: 1823260-2017-02035
• Device Sequence Number: 0
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C513
• Device Catalogue Number: 07649142001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• 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: 77 YR