MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-06-01 for AFP ?1-FETOPROTEIN 04481798190 manufactured by Roche Diagnostics.
[46309265]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[46309266]
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).
Patient Sequence No: 1, Text Type: D, B5
[49975741]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00703 |
| MDR Report Key | 5691611 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-06-01 |
| Date of Report | 2016-07-20 |
| Date of Event | 2016-05-12 |
| Date Mfgr Received | 2016-05-12 |
| Date Added to Maude | 2016-06-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFP ?1-FETOPROTEIN |
| Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
| Product Code | LOJ |
| Date Received | 2016-06-01 |
| Model Number | NA |
| Catalog Number | 04481798190 |
| Lot Number | 133108 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-01 |