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

Model Number AFP

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

The initial reporter questioned high results not corresponding to the clinical picture for 1 patient tested for elecsys afp assay (afp) on a cobas 8000 e 602 module.The results were believed to be too high as the patient has no signs or symptoms of any disease; other results (thyroid, other tumor markers) and examinations (routine blood and b-ultrasonic) showed no abnormalities.The patient is healthy and has no other known disease.The patient does not take any medication and does not receive any treatment.It is not known if the patient takes any dietary supplements.The initial result from the e602 module was 30956 ng/ml.The sample was repeated with a result of 36091 ng/ml.Another result from the e602 module was allegedly 33639 ng/ml.The results were reported outside of the laboratory.The afp results were reported to be similar using other methods.The e602 module serial number was (b)(4).

Manufacturer Narrative

Medwatch field address 2 continued: (b)(6).The customer suspected an interference and performed a polyethylene glycol precipitation (peg) experiment and a spike experiment using calf serum: the peg experiment result was 16433 ng/ml.The calf serum experiment result was 6928 ng/ml.Calibration was last performed on (b)(6) 2022 and was acceptable.In this case, calibration was last performed 4 months ago.Product labeling states: renewed calibration is recommended as follows: after 1 month (28 days) when using the same reagent lot.After 7 days (when using the same reagent kit on the analyzer).As required: e.G.Quality control findings outside the defined limits.The qc material used by the customer expired in apr-2021.The measuring cells were last replaced in (b)(6) 2021.Sample material from the patient was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

Medwatch field b6 was updated.The patient does not have liver disease (eg: liver cancer, alcoholic liver disease), hepatitis, cirrhosis or any type of ovarian cancer.It was clarified that the patient does not take any dietary supplements or traditional medicine.

Manufacturer Narrative

The patient sample was received for investigation.The customer's high results were reproduced during the investigation (> 30000 ng/ml).A dilution experiment was performed with good linearity results; there were no signs of an interference and no implausible results.The sample was tested by the elecsys method and the elisa method and similar results were obtained: a mean result 40096 ng/ml (elecsys) and a mean result of 31620 ng/ml (elisa).The investigation noted that the experiments performed by the customer also do not indicate an interference.It is possible for healthy adults to have elevated afp results that may be caused by the hereditary persistence of -fetoprotein (hpafp).Based on the information available, there is no evidence of an interference in the patient sample causing the high afp results.The investigation determined the high afp results, in this case, are considered to be the true results.The investigation did not identify a product problem.The specific 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15159577
• MDR Text Key: 304818056
• Report Number: 1823260-2022-02283
• Device Sequence Number: 1
• Product Code: LOJ
• UDI-Device Identifier: 04015630920716
• UDI-Public: 04015630920716
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: AFP
• Device Catalogue Number: 04481798190
• Device Lot Number: 559382
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• 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
• Patient Sequence Number: 1