MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number	COBAS 8000 CORE
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned results for 1 patient tested for elecsys insulin (insulin) on a cobas 8000 core unit.Insulin results were obtained from a fasting sample, a sample 1 hour after the fasting sample and a sample 2 hours after the fasting sample.The insulin results from the fasting sample and the sample 2 hours later were discrepant.The initial insulin result from an aliquot of the fasting sample was 0.523 (unit of measure not provided).This sample was repeated and the result was 6.93.During the processing of this sample, a procell/cleancell short alarm was displayed.It was discovered that there was no filter in the set of cleancell.The initial insulin result from an aliquot of the sample 2 hours later was 0.560.This sample was repeated and the result was 13.57 with a data flag.The primary tube was run and the result was 13.43 with a data flag.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The insulin reagent lot number was 269702.The expiration date was not provided.Calibration and qc were within the acceptable range.
Additional Manufacturer Narrative
The insulin unit of measure was uu/ml.
Additional Manufacturer Narrative
The insulin reagent expiration date was feb-2019.Multiple sample-related messages were observed in the customer's alarm trace data.The field service engineer (fse) visited the customer site and no issues were identified during a hardware check.Fibrin strands were present in the sample.Based on the qc data, a general reagent issue can be excluded.Based on the information provided, the investigation was unable to find a definitive root cause.

• Brand Name: COBAS 8000 CORE UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7691236
• Report Number: 1823260-2018-02346
• Device Sequence Number: 10993095
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 4015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K100853
• 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
• Report Date (Section B): 09/04/2018

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: COBAS 8000 CORE
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/02/2018; 07/02/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/13/2018; 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HIGH CHOLESTEROL MEDICATION; HYPERTENSION MEDICATION