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 2016-07-08 for FOLATE III 07559992190 manufactured by Roche Diagnostics.
[49074925]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[49074926]
The customer stated that last year, they had a complaint concerning higher patient values obtained with folate iii (fol3) on a cobas 6000 analyzer. Patient values were higher when compared to values from an abbott architect analyzer. The abbott results were believed to be correct. No further details were provided regarding this previous issue. The fol3 reagent has since been re-standardized. The customer then continued to work with the new re-standardized reagent and had no issues. The customer has now called back reporting that they now continue to have issues with the assay. They state that when patient values recover over the measuring range and dilution of samples is required, the diluted sample result is too high when compared to results from the abbott analyzer. The customer provided an example for one patient sample that had an erroneous fol3 result which was reported outside of the laboratory. The sample initially resulted with a value over the measuring range and was accompanied by a data flag indicating as such. No specific value was provided for this result. The sample was manually diluted at a 1:2 dilution, then resulted with a final value of 32 ng/ml. The 32 ng/ml value was reported outside of the laboratory. The hematologist did not believe the result, so the sample was sent to another laboratory for testing on an abbott architect analyzer. The result from the abbott architect analyzer was 16. 3 ng/ml. The customer stated that they believe that when they dilute samples, some kind of interference with the fol3 assay is involved. The patient was not adversely affected. The serial number of the cobas 6000 analyzer is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[50756575]
The result from the abbott architect analyzer was confirmed to be 16. 30 ug/l. The units of measure have been updated from ng/ml to ug/l.
Patient Sequence No: 1, Text Type: N, H10
[50864029]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. A reagent issue can most likely be excluded based on the provided control data. Possible root causes may be related to the sample being hemolytic, evaporation effects on the sample, or the sample was from a patient who was not fasting.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00875 |
| MDR Report Key | 5778304 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-08 |
| Date of Report | 2016-08-01 |
| Date of Event | 2016-06-17 |
| Date Mfgr Received | 2016-06-21 |
| Date Added to Maude | 2016-07-08 |
| 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 | 2016-07-08 |
| Model Number | NA |
| Catalog Number | 07559992190 |
| Lot Number | ASKU |
| 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 | 2016-07-08 |