MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C502
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) visited the customer site.The fse noted that the instrument and data manager flagged a sample error and there were multiple tests where there was no numeric result.The fse inspected the instrument and the customer ran acceptable qc.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for gluc3 glucose hk (gluc3) on a cobas 8000 c 502 module.The initial result was 172 mg/dl.This result was reported outside of the laboratory where it was questioned by the physician.The repeat results were 110 mg/dl, 110 mg/dl, and 111 mg/dl.These results were believed to be correct.The gluc3 reagent lot number was 65281701 with an expiration date of 31-oct-2023.
Additional Manufacturer Narrative
Calibration was last performed on 17-nov-2022 with acceptable results.Qc was acceptable.The sample was spun for 5 minutes at 5100 (unit of speed not provided).Based on the type of sample tube used, the recommended centrifugation time is 10 minutes.Two "abnormal aspiration" errors were observed on the alarm trace data.One of the errors occurred around the time of the discrepant result.These alarms are indicators of possible poor sample quality.The investigation determined the event was due to pre-analytical handling issues at the customer site.The issue was resolved by repeating the sample.

• Brand Name: COBAS 8000 C 502 MODULE
• 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: 16060532
• Report Number: 1823260-2022-04209
• Device Sequence Number: 2044648
• Product Code: JJE
• UDI-Device Identifier: 04015630920297
• UDI-Public: 04015630920297
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: C502
• Device Catalogue Number: 05964067001
• 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: 12/02/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 01/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE ATTACHED DOCUMENT "PATIENT MEDICATIONS"
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 68 KG