MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2 CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number 03263991190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The customer stated that they received erroneous results for four patient samples tested for crep2 creatinine plus ver.2 on a cobas 6000 c (501) module.The customer stated that the analyzer switched from using their current crep2 reagent pack to using a standby pack.The affected samples appeared to be tested using the standby pack and that there were no issues with sample results measured from the current pack.The third patient sample also had an erroneous result for ise indirect (b)(6) for gen.2.This medwatch will apply only to the crep2 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to (b)(6).All erroneous initial results were reported outside of the laboratory.The repeat results were believed to be correct.The first patient sample initially resulted with a crep2 value of 3.29 mg/dl.When repeated on (b)(6) 2018, the sample resulted with a crep2 value of 0.74 mg/dl.The second patient sample, from a (b)(6) year old female patient, initially resulted with a crep2 value of 5.90 mg/dl.When repeated on (b)(6) 2018, the sample resulted with a crep2 value of 0.91 mg/dl.The third patient sample, from a (b)(6) year old female patient, initially resulted with a crep2 value of 5.38 mg/dl.When repeated on (b)(6) 2018, the sample resulted with a crep2 value of 1.04 mg/dl.This sample initially resulted with a (b)(6) value of 3.73 mmol/l, which repeated as 4.3 mmol/l on (b)(6) 2018.The fourth patient sample, from a (b)(6) year old female patient, initially resulted with a crep2 value of 5.37 mg/dl.When repeated on (b)(6) 2018, the sample resulted with a crep2 value of 0.87 mg/dl.The second patient was transferred to the intensive care unit based on the erroneous result, but was later transferred elsewhere once the correct result was received.No adverse events were alleged to have occurred with all patients.The customer replaced the crep2 reagent pack, then ran calibration and controls.Controls were within specification.The field service engineer determined that the analyzer was functioning properly.Precision testing showed good results.He stated that it appears that the reagent pack that was on board the system caused an issue since it was at the end of the its total pack volume.The issue with the erroneous crep2 values was resolved by the customer and engineer actions.Calibration and controls tested prior to the event were ok.For the issue with the erroneous crep2 values, the investigation could not identify a product problem.The cause of this event could not be determined.

• Brand Name: CREP2 CREATININE PLUS VER.2
• Type of Device: 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7854983
• MDR Text Key: 119661469
• Report Number: 1823260-2018-03021
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 4015630919215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 03263991190
• Device Lot Number: 30284701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 91 YR