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 2015-09-16 for ELECSYS IGE II IMMUNOASSAY 04827031190 manufactured by Roche Diagnostics.
[26501371]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[26501372]
The customer reported that they received erroneous results for one patient sample tested for immunoglobulin e (ige). The sample results were not linear when diluting the sample. The sample initially resulted as 1902 iu/ml and this value was reported outside of the laboratory. The sample was diluted times 2 and repeated, resulting as > 4551 iu/ml. The > 4551 iu/ml value was also reported outside of the laboratory. The sample was then diluted times 10 and repeated, resulting as 7732 iu/ml. The 7732 iu/ml value was also reported outside of the laboratory. The sample was provided for investigation, where it was tested on a cobas 8000 analyzer on (b)(6) 2015. During the investigation, the sample initially resulted as 2456 iu/ml. The sample was then repeated at a times 2 dilution, resulting as >5000 iu/ml. The sample was then repeated at a times 5 dilution, resulting as 7400 iu/ml. The sample was then repeated at a times 10 dilution, resulting as 7961 iu/ml. The sample was also repeated at a times 20 dilution, resulting as 8052 iu/ml. The investigation found that the customer's results were reproducible and no signs of interference were noted. It was asked, but it is not known if the patient was adversely affected. No adverse events were alleged. The serial number of the e602 analyzer used at the customer site was asked for, but not provided. Ige reagent lot number 181429, with an expiration date of june 2016 was used on the cobas 8000 analyzer which was used for investigation.
Patient Sequence No: 1, Text Type: D, B5
[28318533]
It was stated that a sample from the patient was diluted and measured 3 months ago, resulting as 7000 iu/ml for ige. Upon further investigations of the sample in question, testing was performed with a different ige assay using feia methodology. The result obtained with this assay was 10600 iu/ml.
Patient Sequence No: 1, Text Type: N, H10
[31054376]
A specific root cause could not be determined. Further investigation of the sample was not possible as the volume of the sample was not sufficient enough for further investigations. A general reagent issue could not be detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04177 |
| MDR Report Key | 5080742 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-09-16 |
| Date of Report | 2015-10-23 |
| Date of Event | 2015-09-02 |
| Date Mfgr Received | 2015-09-03 |
| Date Added to Maude | 2015-09-16 |
| 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 | ELECSYS IGE II IMMUNOASSAY |
| Generic Name | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) |
| Product Code | JHR |
| Date Received | 2015-09-16 |
| Model Number | NA |
| Catalog Number | 04827031190 |
| Lot Number | 181429 |
| ID Number | NA |
| Device Expiration Date | 2016-06-29 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-16 |