MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2; ENZYMATIC METHOD, CREATININE

Model Number	CREP G2
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received questionable results for multiple samples from the same patient tested with the crep2 (creatinine plus ver.2) assay on a cobas 8000 c702 module, serial number (b)(4).An interference affecting the roche results is suspected.(b)(6) 2022.Venipuncture time of patient sample 1: 18:00.Patient sample 1 initially resulted in a crep2 value of < -42 umol/l, accompanied by a data flag, and repeated as < -28 umol/l, accompanied by a data flag.Venipuncture time of patient sample 2: 20:06.Patient sample 2 initially resulted in a crep2 value of < -25 umol/l, accompanied by a data flag and repeated as < -35 umol/l accompanied by a data flag.(b)(6) 2022, a sample of the patient was measured with a 1:2, 1:5, and 1:10 dilution, resulting in crep2 values of 73 umol/l, 14 umol/l and 2 umol/l.It was asked but it is unknown if the results are from a different sample collected from the patient or if these were repeats from any of the other samples.(b)(6) 2022, patient sample 3 resulted in a crep2 value of < -53 umol/l, accompanied by a data flag.Patient sample 3 was repeated in a different laboratory on a cobas c 502 analyzer, resulting in a crep2 value of 125.8 umol/l.(b)(6) 2022, patient sample 4 initially resulted in a crep2 value of < -74 umol/l, accompanied by a data flag and repeated as < - 32 umol/l, accompanied by a data flag.Additional results for one sample were provided.It was asked but it is unknown when this data was measured and with what sample.The results of the sample are as follows: the sample initially resulted in a crep2 value of < -42 umol/l, accompanied by a data flag.The sample was repeated three times, resulting in crep2 values of < -29 umol/l, < -46 umol/l and < -28 umol/l.All results were accompanied by a data flag.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Medwatch field b7 was updated.
Additional Manufacturer Narrative
Three sample aliquots, collected on (b)(6) 2023, and two sample aliquots collected on (b)(6) 2023 from the same patient were provide for investigation.The customer¿s negative crep2 values could be reproduced.Further investigations of the samples determined the issue was consistent with a gammopathic interference.Per product labeling: "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results." the investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field b7 was updated.
Additional Manufacturer Narrative
The investigation did not identify a product problem.

• Brand Name: CREP2
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16214148
• Report Number: 1823260-2023-00194
• Device Sequence Number: 14545507
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K024098
• 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,Followup,Followup,Followup
• Report Date (Section B): 07/17/2023

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 Expiration Date: 05/31/2023
• Device Model Number: CREP G2
• Device Catalogue Number: 05168589190
• Device Lot Number: 65757401
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 03/20/2023; 04/11/2023; 05/31/2023; 06/29/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 04/12/2023; 05/05/2023; 06/28/2023; 07/17/2023
• 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: ALVEDON FORTE TABLET (IF NEEDED); AMLODIPINE TABLET (ONCE A DAY, 1+0+0); BISOPROLOL TABLET (ONCE A DAY, 1+0+0); CHAOS; COMBIVENT (INHALATION, AS NEEDED); ELIQUIS TABLET (TWICE A DAY, 1+0+1); GABAPENTIN CAPSULE (THREE TIMES A DAY, 3+3+3); KAJO'S ORAL SOLUTION (TWICE A DAY, 30+0+30); MIRTAZAPINE (ONCE AT NIGHT); MOXALOL (IF NEEDED); NORADRENALINE; NOREPINEPHRINE ABCUR INFUSION SOLUTION (AS NEEDED); PIPERACILLIN-TAZOBACTAM; PROPAVAN (IF NEEDED); ZOLPIDEM (IF NEEDED)
• Patient Sex: Male