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

Model Number	E602
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned results for multiple patient samples tested for elecsys hiv combi pt (hiv combi) using a particular reagent pack on a cobas 8000 e 602 module.The customer stated the issue began a month ago after preventive maintenance was performed.The customer ran "a few" patient samples and all patient samples showed results of (b)(6) which is "very rare." the customer changed to a different reagent pack and repeated the patient samples.Upon repeating the patient samples, the result for 1 patient sample was discrepant.The initial result was (b)(6).The repeat result was (b)(6).The positive result was believed to be correct.The questionable result was not reported outside of the laboratory.The e602 module serial number was (b)(4).
Additional Manufacturer Narrative
The customer was receiving reagent alarms.The customer ran qc on the new reagent pack and it was acceptable.The field service engineer (fse) could not reproduce the reagent alarms.The fse checked and cleaned multiple parts of the instrument and replaced the mixing paddle.Mechanism checks were successful.The customer ran qc and patient samples with no issues.
Additional Manufacturer Narrative
The suspect medical device was updated.Applicable fields of sections d and g were updated.The hiv combi reagent lot number was 53282700 with an expiration date of 28-feb-2022.The field service engineer (fse) revisited the customer site and replaced the reagent probe and the liquid level detection (lld) board.Adjustments, air purges and mechanism checks were successful.The customer ran qc and samples with no issues.The investigation determined the service actions resolved the issue.

• 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: 13387410
• Report Number: 1823260-2022-00226
• Device Sequence Number: 17564004
• Product Code: JJE
• UDI-Device Identifier: 04015630942497
• UDI-Public: 04015630942497
• 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): Unknown
• 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): 03/01/2022
• 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: 05990378001
• Device Lot Number: 532827
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/01/2022
• 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 Age: 21 YR
• Patient Sex: Male