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 2016-07-22 for AFP ?1-FETOPROTEIN 04481798190 manufactured by Roche Diagnostics.
[50300698]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[50300699]
The customer reported in medwatch report 1823260-2016-00703-00, customer a, had issues with tests for afp a1-fetoprotein (afp) since (b)(6) 2016 when they changed to new reagent lot. During troubleshooting of this issue, patient samples were tested at multiple sites on roche analyzers. As reported in follow up report 1823260-2016-00703-01, the investigation determined the customer's results as reported in mdr 1823260-2016-00703-00 were determined to be correct and there may be a potential issue at one of the sites where comparison testing was performed. This medwatch report is for the site identified as having potential issues, which will be referred to as customer b in this report. Data was provided for 62 patient samples that were tested for afp at customer b compared to customer a. Based on the data provided, the results for 10 patient samples were erroneous. The afp results from customer b were reported outside of the laboratory. Customer a also ran 26 patient samples on roche analyzers at 4 different hospital sites to troubleshoot the issue with the afp test. Based on the results from the multiple comparisons performed, erroneous results for 4 patient samples were generated from customer b. The results from the other 3 hospital sites were comparable to one another. It is unclear whether the comparison data was being used for troubleshooting purposes only or if the afp results from customer b were reported outside of the laboratory for diagnostic purposes. No adverse event occurred. The e602 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[53575853]
It was clarified that the results from customer b were in a different unit of measure than the results from customer a. Customer a was reporting afp results in iu/ml. Customer b was reporting afp results in ug/l.
Patient Sequence No: 1, Text Type: N, H10
[58855986]
Based on the recalculated data provided by the customer in a previous follow-up report, the afp results between customer a and customer b were comparable to one another. Due to this, the investigation stated any false interpretation of results can be excluded. The data provided confirm that the initial differences between the afp results from customer a and customer b were due to an operator error. Customer a was reporting afp results in iu/ml. Customer b was reporting afp results in ug/l. The operators did not notice that the afp results for each site were in different units of measure. Once the conversion factor was applied to the results, the issue with afp results was corrected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01041 |
| MDR Report Key | 5815708 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-07-22 |
| Date of Report | 2016-10-31 |
| Date of Event | 2016-07-14 |
| Date Mfgr Received | 2016-07-06 |
| Date Added to Maude | 2016-07-22 |
| 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 | 2016-07-22 |
| 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 | 2016-07-22 |