MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-04-29 for FOLATE III 07559992190 manufactured by Roche Diagnostics.
[44001098]
(b)(6). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[44001099]
The customer performed method comparisons between the folate iii material number 04476433190 and the restandardized folate iii material number 07559992190. The method comparison showed discrepancies when values were in the low concentration range. Based on the comparison results, the customer does not trust the results from the folate iii assays. The customer provided data for 22 patient samples. Of the data provided, the results for 15 patient samples were discrepant. The customer reported all results outside of the laboratory where the doctor in charge complained about the big difference in results. This medwatch will cover the restandardized folate iii, material number 07559992190. Refer to medwatch with patient identifier (b)(6) for information on the folate iii material number 04476433190 erroneous results. Refer to the attached data for the patient results. No adverse event occurred. The e601 analyzer serial number is (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[45715044]
Additional information for further investigation was requested but was not provided. Since the initial point of contact the customer has had conversations with other medical doctors about the re-standardized folate iii assay with material number (b)(4). After these discussions, the customer is very comfortable with the results received from the re-standardized folate iii assay with material number (b)(4). As the customer is no longer questioning the results, he has declined to provide any additional information for investigation purposes. A specific root cause could not be identified. Customers have been informed that there will be a difference between the results received between the folate iii material number (b)(4) and the re-standardized folate iii material number (b)(4). This information needs to be considered in this method comparison.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00549 |
| MDR Report Key | 5619158 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-29 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-03-03 |
| Date Mfgr Received | 2016-04-06 |
| Date Added to Maude | 2016-04-29 |
| 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 | FOLATE III |
| Generic Name | ACID, FOLIC, RADIOIMMUNOASSAY |
| Product Code | CGN |
| Date Received | 2016-04-29 |
| Model Number | NA |
| Catalog Number | 07559992190 |
| Lot Number | 123242 |
| 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 | 2016-04-29 |