MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFE GEN.2; CREATININE, ALKALINE PICRATE COLORIMETRY

Catalog Number	08057532190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer stated verbally that their qc recovery data was acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable crej2 creatinine jaffé gen.2 results for 1 patient on a cobas pro c 503 analytical unit.The customer questioned the patient's results as they noticed fluctuation across multiple samples and suspect a possible drug interference.On (b)(6)2023, the patient had a crej2 result of 61 umol/l.On (b)(6)2023, the patient had a crej2 result of 170 umol/l and a second result of 140 umol/l.On (b)(6)2023, the patient had a crej2 result of 296 umol/l and a second result of 235 umol/l.On (b)(6)2023, the patient had a crej2 result of 135 umol/l and a second result of 135 umol/l.On (b)(6)2023, the patient had a crej2 result of 57 umol/l and a second result of 272 umol/l.On (b)(6)2023, the patient had a crej2 result of 174 umol/l and a second result of 80 umol/l.On (b)(6)2023, the patient had a crej2 result of 81 umol/l and a second result of 63 umol/l.On (b)(6)2023, the patient had a crej2 result of 57 umol/l.On (b)(6)2023, the patient had a crej2 result of 62 umol/l.On (b)(6)2023, the patient had a crej2 result of 53 umol/l.
Additional Manufacturer Narrative
The patient had the following albumin and crep2 (creatinine plus) results: on (b)(6) 2023, the patient had an albumin result of 26 g/l.On (b)(6) 2023, the patient had a crep2 result of 175 umol/l, a second crep2 result of 142 umol/l, and an albumin result of 27 g/l.On (b)(6) 2023, the patient had a crep2 result of 304 umol/l, a second crep2 result of 239 umol/l, and an albumin result of 25 g/l.On (b)(6) 2023, the patient had a crep2 result of 138 umol/l, a second crep2 result of 137 umol/l, and an albumin result of 22 g/l.On (b)(6) 2023, the patient had a crep2 result of 58.4 umol/l, a second crep2 result of 286 umol/l, and an albumin result of 26 g/l.On (b)(6) 2023, the patient had a crep2 result of 174 umol/l, a second crep2 result of 82.8 umol/l, and an albumin result of 29 g/l.On (b)(6) 2023, the patient had a crep2 result of 74 umol/l, a second crep2 result of 61.4 umol/l, and an albumin result of 25 g/l.On (b)(6) 2023, the patient had a crep2 result of 59.3 umol/l and an albumin result of 25 g/l.On (b)(6) 2023, the patient had a crep2 result of 58.7 umol/l and an albumin result of 25 g/l.On (b)(6) 2023, the patient had a crep2 result of 58.4 umol/l and an albumin result of 28 g/l.Medwatch field d10 and concomitant medical products have been updated.See attached data for patient medication information and diagnosis.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc recovery data provided was acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.The alarm trace showed qc out of range, abnormal aspiration, and photometer check alarms.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: CREATININE JAFFE GEN.2
• Common Device Name: CREATININE, ALKALINE PICRATE COLORIMETRY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18113704
• Report Number: 1823260-2023-03572
• Device Sequence Number: 7609990
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (Y/N): Y
• Initial Reporter Country: HK
• 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,Followup
• Report Date (Section B): 05/14/2024

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 Catalogue Number: 08057532190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 01/25/2024; 04/22/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 02/20/2024; 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ACETYLCYSTEINE; ALBUMIN; AMIKACIN; AUGMENTIN; BROMHEXINE HCL; DEXTROSE; ERTAPENEM; ESOMEPRAZOLE (MAGNESIUM); FLEET; FUROSEMIDE (SODIUM); FUROSEMIDE (SODIUM); GABAPENTIN; GELATIN; GELATIN INFUSION; INSULIN ACTRAPID HM; KLEAN PREP; LACTATED RINGER; LIDOCAINE; MEROPENEM; MEROPENEM; METRONIDAZOLE; MORPHINE SULFATE; ONDANSETRON (HCL); OXYCODONE HCL; PARACETAMOL; PHOSPHATE SANDOZ; PHYTOMENADIONE; POTASSIUM CL + DEXT 5%; SODIUM CHLORIDE; TAZOCIN
• Patient Age: 51 YR
• Patient Sex: Female