MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer received questionable low gluc3 glucose hk and crplx c-reactive protein results for one patient sample from the cobas 6000 c 501 module.The initial glucose result was 4.5 mg/dl and the repeat result was 117.5 mg/dl.On (b)(6) 2018, the repeat result was 115 mg/dl.The initial crplx result was 1.22 mg/l.The repeat results on (b)(6) 2018 were 50.26 mg/l and 50.79 mg/l.Only the erroneous crplx result was reported outside of the laboratory.There was no allegation of an adverse event.The glucose reagent lot number was 33012601 with an expiration date of 30-jun-2019.The crplx reagent lot number was 31645201 with an expiration date of 30-nov-2019.
Additional Manufacturer Narrative
The qc data showed instrument precision was acceptable.The reaction kinetics and analyzer alarm trace indicated there was abnormal sample pipetting.The customer was not following the recommended frequency for probes cleaning.The sample clotting time and centrifugation time were less than the tube manufacturer's recommendation.There was no indication of a general product problem.The investigation was unable to find a definitive root cause.

• Brand Name: COBAS 6000 C (501) MODULE
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7724156
• Report Number: 1823260-2018-02281
• Device Sequence Number: 1369464
• Product Code: JJE
• UDI-Device Identifier: 04015630913633
• UDI-Public: 04015630913633
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 08/28/2018

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: C501
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1