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

Model Number	COBAS 8000 CORE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hcg+ss results for 8 patient samples on a cobas 8000 core unit.Sample 1: the initial result was 10000 miu/ml with a >test data flag.A 1:20 dilution was performed and the result was 15.4 miu/ml.The sample was retested and the result was 10000 miu/ml with a >test data flag.The repeated result was 12545 miu/ml.Sample 2: the initial result was 10000 miu/ml with a >test data flag.A 1:20 dilution was performed and the result was 53.3 miu/ml.The sample was retested and the result was 10000 miu/ml with a >test data flag.The repeated result was 48190 miu/ml.Sample 3: the initial result was 10000 miu/ml with a >test data flag.A 1:20 dilution was performed and the result was 72.2 miu/ml.The sample was retested and the result was 10000 miu/ml with a >test data flag.The repeated result was 37854 miu/ml.The sample was tested again and the result was 0.200 miu/ml with a test data flag.A 1:20 dilution was performed and the result was 30.6 miu/ml.The sample was retested and the result was 10000 miu/ml with a >test data flag.Sample 5: the initial result was 20.9 miu/ml.A 1:20 dilution was performed and the result was 25025 miu/ml.Sample 6: a 1:20 dilution was performed and the result was 166 miu/ml.The sample was repeated with a 1:20 dilution and the result was 65672 miu/ml.Sample 7: a 1:20 dilution was performed and the result was 38 miu/ml.The sample was repeated with a 1:20 dilution and the result was 35016 miu/ml.Sample 8: a 1:20 dilution was performed and the result was 27.8 miu/ml.The sample was repeated with a 1:20 dilution and the result was 22983 miu/ml.The reagent lot number is 584575.The expiration date was not provided.
Additional Manufacturer Narrative
Facility name: (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.A reagent related issue was excluded as the same reagent was used for the initial and repeat results.

• Brand Name: COBAS 8000 CORE UNIT
• Common Device Name: 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15457581
• Report Number: 1823260-2022-02891
• Device Sequence Number: 6897289
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 04015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 05641446001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown