MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AFP ¿1-FETOPROTEIN; KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Catalog Number 04481798190

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer has had issues with tests for afp a1-fetoprotein (afp) since (b)(6) 2016 when they changed to a new reagent lot.The previous afp reagent lot number was 187903.The new afp reagent lot number is 133108.The expiration dates were not provided.The customer was having issues with their quality control values and began to question the patient results.The customer sent 3 patient samples tested for afp to another hospital for testing.The results for all 3 patient samples were erroneous when compared to the instrument from the other hospital.The type of instrument was not provided.It is not known if any erroneous results were reported outside of the laboratory.Patient 1 initial result from the e602 analyzer was 75 iu/ml.The repeat result from the other hospital's instrument was 107 (unit of measure not provided).Patient 2 initial result from the e602 analyzer was 378 iu/ml.The repeat result from the other hospital's instrument was 570 (unit of measure not provided).Patient 3 initial result from the e602 analyzer was 420 iu/ml.The repeat result from the other hospital's instrument was 630 (unit of measure not provided).The customer has also sent the samples to a second hospital and indicated that the afp results from the second hospital were "very accurate." the specific values were not provided.No adverse event occurred.The e602 analyzer serial number was (b)(4).

Manufacturer Narrative

The customer has been troubleshooting the roche afp assay with lot number 133108 by running patient samples on other roche analyzers at different hospital sites.The customer performed a method comparison with 26 patient samples and tested the samples for afp at the customer site and a 3rd hospital.The results were comparable.Since these results were comparable, the customer sent the samples to the "other hospital" mentioned in the initial report and a 4th hospital.The results from the 4th hospital were comparable to the results from the customer site.The results from the "other hospital" mentioned in the initial report were higher than the results from the customer site and the other 2 sites which indicates there may be an issue with afp tests at the "other hospital." based on the results from the multiple comparisons performed and additional information provided for investigation, a general issue with the instrument and reagent can be excluded.No performance issues with afp were identified at the customer site.

• Brand Name: AFP ¿1-FETOPROTEIN
• 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: 5691611
• MDR Text Key: 46309265
• Report Number: 1823260-2016-00703
• Device Sequence Number: 1
• Product Code: LOJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K981282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04481798190
• Device Lot Number: 133108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2016
• 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