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

Model Number AFP

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reported complained of elecsys afp assay results for 1 patient from a cobas 6000 e 601 module that were not matching the patient's clinical picture.The initial afp result was >1000 iu/ml with a data flag.The patient sample was repeated using a 1:50 dilution and a result of 1329 iu/ml was obtained.A comparable result was also obtained for a siemens analyzer with an approximate afp result of 1800 iu/ml.The suspected high result was reported outside of the laboratory.There was no allegation of an adverse event.The customer believes these high results are not matching the patient's clinical finding as magnetic resonance imaging (mri) imaging was negative.The cobas e601 serial number was (b)(4).The investigation is currently ongoing.

Manufacturer Narrative

Calibration before the event was within acceptable range.Qc was acceptable on the day of the event.Based on the provided data, there is no indication of a general reagent or analyzer problem.The customer was unable to provide the sample for further investigation.The investigation did 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
• MDR Report Key: 8569513
• MDR Text Key: 143707357
• Report Number: 1823260-2019-01615
• Device Sequence Number: 1
• Product Code: LOJ
• Combination Product (y/n): N
• PMA/PMN Number: K981282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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 Model Number: AFP
• Device Catalogue Number: 04481798190
• Device Lot Number: 34949001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1