MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number	05168589190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer stated that they received erroneous results for one patient sample tested with crep2 creatinine plus ver.2 on a cobas 8000 c 702 module.The results did not correspond to the clinical picture of the patient.The sample was initially tested on another c 702 analyzer, resulting with a crep2 value of -4 umol/l.The sample was repeated on the complained c 702 analyzer, resulting with a value of 2 umol/l.The sample was repeated on the complained c 702 analyzer, resulting as 3 umol/l.The results were reported to the doctor who did not believe the results fit the patient's clinical picture.The patient normally has crep2 values of 35 to 45 umol/l.No adverse events were alleged to have occurred with the patient.The c 702 analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The investigation found the results are consistent with acetaminophen/paracetamol intoxication.According to product labeling for the assay: acetaminophen intoxications are frequently treated with n-acetylcysteine.N-acetylcysteine at a plasma concentration above 333 mg/l and the acetaminophen metabolite n-acetyl-p-benzoquinone imine (napqi) independently may cause falsely low results.

• Brand Name: CREATININE PLUS VER.2
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7915337
• Report Number: 1823260-2018-03310
• Device Sequence Number: 2255733
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K024098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 05168589190
• Device Lot Number: 35181201
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: ARIPIPRAZOLE (ANTIPSYCHOTICS); BENZODIAZEPINES; CANNABIS; CHEMADRIN (ANTIPARKINSON); METHADONE; OPIOIDS; PARACETAMOL; PREGABLIN (ANTIEPILEPSY / PAIN)
• Patient Age: 46 YR