MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALIBRATOR CLINICAL CHEMISTRY; ISE STANDARD HIGH

Model Number C311

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of questionable results for 13 patient samples tested for ise indirect na, k, cl for gen.2 on a cobas 4000 c (311) stand alone system.Of the data provided 1 patient¿s results were a reportable malfunction for sodium, potassium, and chloride, 1 patient¿s results were a reportable malfunction for sodium and potassium, and 5 patient¿s results were a reportable malfunction for sodium.Please refer to (b)(6) of this medwatch for patient data that meets criteria of a reportable malfunction.The initial results were reported outside of the laboratory.It was unknown to the customer which results were correct.There was no adverse event.The sodium electrode lot was a4454.The potassium electrode lot was i2853.The chloride electrode lot was n4294.The expiration dates for the electrodes were requested but not provided.The field engineering specialist found cut tubing in the reagent syringe flow path.He replaced the tubing along with replacing a few solenoid valves.He performed operational and mechanical checks which passed.The customer ran calibration and qc all which were acceptable.

Manufacturer Narrative

Further investigation showed that the provided calibration data showed a good general performance of the ise unit itself as the electromotive force (emf) values for the internal standard were stable.The emf readings for the sodium standards (s1, s2, s3) showed a discrepancy between the calibrations.The calculated internal standard concentration changed from 131 mmol/l up to 140 mmol/l, which is a similar discrepancy that was seen in the patient results.The chloride and potassium results looks similar.This can be caused by not properly handling the calibrator standards.The customer also had an incorrect target value setting for one of the sodium calibrator standards that would have caused a negative shift in patient and qc results.The customer stated that there have been no further issues.Unique identifier (udi)# (b)(4).The cobas 4000 c (311) stand alone system serial number was (b)(4).

• Brand Name: CALIBRATOR CLINICAL CHEMISTRY
• Type of Device: ISE STANDARD HIGH
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7078444
• MDR Text Key: 94844839
• Report Number: 1823260-2017-02811
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963627
• 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,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C311
• Device Catalogue Number: 11183982216
• Device Lot Number: 243965
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• 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: 30 YR
• Patient Weight: 64