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 2015-10-08 for IMMUNOGLOBULIN E 11930419122 manufactured by Roche Diagnostics.
[27823110]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[27823111]
The customer received questionable immunoglobulin e (ige) results for one patient from an unknown roche analyzer. The initial result was flagged as greater than the test range and the sample was reanalyzed with a 1:20 dilution. The result that was released was 44,000 iu/ml. Two weeks later on an unspecified date, the patient had ige tested at another hospital using the beckman coulter image and the result was 125 iu/ml. The patient's doctor asked why the initial result did not correlated with what the other hospital released. On (b)(6) 2015, the patient was retested and the result was 2500 iu/ml flagged as greater than test range. When tested with a 1:20 dilution, the result was 50,000 flagged as greater than test range. On (b)(6) 2015, the pathologist decided to check serum protein electrophoresis and the gamma levels were normal. She expected them to be elevated due to high ige levels. The pathologist believed the results were not correct. On (b)(6) 2015, a sample from the patient was tested at another site using a cobas e601 analyzer and the result was 2500 iu/ml flagged as greater than the test range. When diluted 1:20, the result was 49448 iu/ml. No adverse event adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
[29735203]
The analyzer involved was a cobas e601. Information was provided concerning the results: "1st run within institution around 40000 iu/ml (cobas 6000) 1st extraction 2nd run different institution roughly 140 iu/ml (beckman coulter immage) 2nd extraction 3rd run within institution around 40000 iu/ml (cobas 6000) 3rd extraction 4th run different institution with roche cobas 6000 same sample as with 3rd extraction".
Patient Sequence No: 1, Text Type: N, H10
[30883437]
A sample from the patient was submitted for investigation and the customer's results could be reproduced.
Patient Sequence No: 1, Text Type: N, H10
[33614059]
Sample from the patient was submitted for investigation and the customer's results were confirmed on a cobas e601 and a siemens centaur analyzer. Based on these results, it was believed the result from the beckman coulter was likely incorrect. A general reagent issue with the roche ige assay could be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04291 |
| MDR Report Key | 5134659 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-08 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-08-01 |
| Date Mfgr Received | 2015-09-20 |
| Date Added to Maude | 2015-10-08 |
| 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 | IMMUNOGLOBULIN E |
| Generic Name | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) |
| Product Code | JHR |
| Date Received | 2015-10-08 |
| Model Number | NA |
| Catalog Number | 11930419122 |
| Lot Number | 181429 |
| ID Number | NA |
| Device Expiration Date | 2016-05-30 |
| 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 | 2015-10-08 |