MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MG2 MAGNESIUM GEN.2; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number 06481647190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported the analyzer switched to a standby mg2 magnesium gen.2 reagent pack and the tech noticed several low results were generated.The customer used cobas 6000 c (501) module serial number (b)(4).The samples were repeated on a different cobas c501 analyzer and the results did not match.Data was provided for four patient samples.Sample 1: original result was 0.7 mg/dl and the repeat result was 1.7 mg/dl.Sample 2: original result was 0.6 mg/dl and the repeat result was 1.6 mg/dl.Sample 3: original result was 1.0 mg/dl and the repeat result was 2.0 mg/dl.Sample 4: original result was 0.9 mg/dl and the repeat result was 1.9 mg/dl.The repeat results were believed to be correct.The original results were released from the laboratory, but corrected reports were sent within a few hours.There was no adverse event as the doctor was contacted prior to any treatment.The original results for other assays for the samples in question matched the historical results for the patients and were not repeated.There were no issues with any other assays.The tech recalibrated the suspect magnesium reagent cassette and ran qc which was acceptable.The remaining tests using this reagent cassette were all acceptable.The field service representative could not find a cause.He ran precision testing with all results on the mean.He verified the operational and mechanical checks passed.A specific root cause could not be determined.Additional information for further investigation was requested but was not provided.As the issue did not reoccur with the other reagent cassettes, a customer handling issue with the suspect reagent causing contamination or denaturation was the most likely cause of the event.

• Brand Name: MG2 MAGNESIUM GEN.2
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• 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: 6151178
• MDR Text Key: 62377110
• Report Number: 1823260-2016-01914
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/07/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 06481647190
• Device Lot Number: 16186501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/07/2016
• 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