MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	I400+
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with crep2 (creatinine plus ver.2) on a cobas integra 400 plus analyzer.Patient 1, measured on (b)(6) 2022: the sample initially resulted in a crep2 value of 100 ¿mol/l.The result was reported outside of the laboratory and did not match the patient's history.The sample was repeated, resulting in a value of 51 ¿mol/l.Patient 2, measured on (b)(6) 2022: the sample initially resulted in a crep2 value of 131 ¿mol/l, accompanied by a data flag.The result was reported outside of the laboratory and did not match the patient's history.The sample was repeated two times, resulting in values of 69 ¿mol/l and 68 ¿mol/l.The crep2 reagent lot was 635960 with an expiration date of 31-jan-2023.
Additional Manufacturer Narrative
Calibration results were acceptable.Quality controls were mostly within range, but level 2 control was outside of range on (b)(6) 2022.Upon review of the alarm trace, no relevant alarm was observed.Upon review of the reaction data, the initial values of both samples showed reaction curves that suggested a reagent carryover.The extra wash cycles were not correctly implemented on the analyzer and were updated.Based on the provided data, a general reagent issue can be excluded.The investigation could not identify a product problem.The investigation determined the issue was consistent with a user error due to incorrectly implemented extra wash cycles.

• Brand Name: COBAS INTEGRA 400 PLUS ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15868216
• Report Number: 1823260-2022-03766
• Device Sequence Number: 17445410
• Product Code: JJE
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K951595
• 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): 12/21/2022

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: I400+
• Device Catalogue Number: 03245233001
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/21/2022
• 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