MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS AFP ASSAY; KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Catalog Number 04491742190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received an erroneous result for one patient sample tested with the elecsys afp assay on a cobas 6000 e 601 module.The erroneous result was not reported outside of the laboratory.The sample initially resulted with an afp value of 7.3 ng/ml.The customer then ran controls and these were outside of range.The customer tried re-calibrating, but calibration failed.The customer then placed a new reagent pack on the analyzer and repeated calibration, which passed.Controls were then tested and were acceptable.The sample was repeated using the new reagent pack and the result was 4.7 ng/ml.No adverse events were alleged to have occurred with the patient.The serial number of the e 601 analyzer is (b)(4).The customer's refrigerator temperature was investigated and it was determined that the refrigerator temperature was approximately negative eleven degrees celsius for 8 hours.Per product labeling, the afp reagent should be stored at 2 - 8 degrees celsius and should not be frozen.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS AFP ASSAY
• Type of Device: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
• 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: 8495828
• MDR Text Key: 141357846
• Report Number: 1823260-2019-01398
• Device Sequence Number: 1
• Product Code: LOJ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K981282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 04491742190
• Device Lot Number: 34018900
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2019
• 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