MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 4000 C (311) STAND ALONE SYSTEM; CLINICAL CHEMISTRY ANALYZER

Model Number	C311
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer received a questionable crej2 creatinine jaffé gen.2 result for one patient and a questionable ise indirect gen.2 sodium result for one other patient.Patient 1 initial creatinine result was 2 mg/dl and the repeat result was 4.2 mg/dl.Patient 2 initial sodium result was 132 mmol/l and the repeat result was 142 mmol/l.No erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The reagent/electrode lot numbers and expiration date dates were requested but were not provided.
Additional Manufacturer Narrative
For the issue with creatinine, a general reagent issue could be ruled out based on calibration and qc data.
Additional Manufacturer Narrative
The calibration data provided was within acceptable range.The quality control data provided was within the acceptable range.The lot number of the reagent lot used was 330109 with an expiration date 31-dec-2018.The precision check for creatinine indicated reagent pipetting was performing correctly.The investigation was unable to find a definitive root cause.
Additional Manufacturer Narrative
Na.

• Brand Name: COBAS 4000 C (311) STAND ALONE SYSTEM
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7725505
• Report Number: 1823260-2018-02477
• Device Sequence Number: 1329834
• Product Code: JJE
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C311
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 07/11/2018; 07/11/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/06/2018; 08/30/2018; 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1