MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E602
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter alleges there is an issue with the elecsys vitamin d gen.3 calset lot 525313.The reporter stated they started using the calibrator lot in (b)(6) 2021 and precision was poor.The customer switched to another lot of calibrator and validations performed with this lot were approved.The reporter stated they started using calibrator lot 525313 again starting on (b)(6) 2021.In the following days, the reporter stated they received questionable low patient results for approximately 200 patient samples tested with the elecsys vitamin d gen.3 assay.The reporter provided specific data for six patient samples that had discrepant vitamin d results.The samples were initially tested at the customer site on a cobas 8000 e 602 module (serial number (b)(4)) on (b)(6) 2021.The initial measurements were reported outside of the laboratory to a clinician.The first sample was repeated at the customer site on the same e602 analyzer on (b)(6) 2021.Samples 2-6 were sent to a second site for repeat testing on a cobas 6000 e 601 module (serial number (b)(4)) on (b)(6) 2021.All repeat values were believed to be correct.The first sample initially resulted in a vitamin d value of 25.18 nmol/l, which repeated as 44.38 nmol/l on (b)(6) 2021.The second sample initially resulted in a vitamin d value of 41.02 nmol/l, which repeated as 62.04 nmol/l.The third sample initially resulted in a vitamin d value of 33.3 nmol/l, which repeated as 55.1 nmol/l.The fourth sample initially resulted in a vitamin d value of 25.32 nmol/l, which repeated as 46.07 nmol/l.The fifth sample initially resulted in a vitamin d value of 19.52 nmol/l, which repeated as 37.58 nmol/l.The sixth sample initially resulted in a vitamin d value of 19.92 nmol/l, which repeated as 38.84 nmol/l.The vitamin d reagent lot number was 557617; the expiration date was requested but not provided.
Additional Manufacturer Narrative
Calibrator lot 525313 was used at both sites.At the second site, control recovery was good when using calibrator lot 525313.Two calibrator lots were in use at the customer site, lots 525313 and 555921.Fluctuation in calibrator signals were seen between (b)(6) 2021 on e 602 serial number (b)(6) when lot 525313 was in use.Many calibrations with 3 different kits were performed within a short time with signals that were too low for the first calibrator level.This is consistent with a handling issue.Upon further review of calibration data, it was observed that the recommended recalibration frequency with single kits after 7 days is not always followed.Upon review of quality control data for e 602 serial number (b)(6), most data is within range.Some data was outside of range in november 2021 when calibrator lot 525313 was in use.Upon review of control data from the second site, qc precision was more stable and controls were not outside of range except for one measurement.No major findings were observed when checking the customer instrument (e 602 serial number (b)(6)).Based on the available data a generic issue with the reagent or used calibrator is not evident.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1., d2., d4., g1., and g4.Have been updated.

• Brand Name: COBAS 8000 E 602 MODULE
• Common Device Name: IMMUNOCHEMISTRY 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13043023
• Report Number: 1823260-2021-03781
• Device Sequence Number: 3967317
• Product Code: JJE
• UDI-Device Identifier: 07613336172667
• UDI-Public: 07613336172667
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 03/18/2022
• 2 Devices were Involved in the Event: 1 2

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: E602
• Device Catalogue Number: 09038116190
• Device Lot Number: 525313
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/19/2022
• 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