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 2015-11-18 for IMMUNOGLOBULIN E 04827031190 manufactured by Roche Diagnostics.
[31571780]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[31571781]
The customer complained of erroneous results for 1 patient tested for immunoglobulin e (ige ii). It is not known if any erroneous results were reported outside of the laboratory. The initial ige ii result from a serum sample was 1555 iu/ml. The sample was repeated on (b)(6) 2015 and the result was 1487 iu/ml. The sample was diluted x2 and the result was >5000 iu/ml. The sample was diluted x10 and the result was 6906 iu/ml. On (b)(6) 2015, a new sample was obtained and the result from a serum sample was 1236 iu/ml. This sample was diluted x2 and the result was > 4454 iu/ml. The sample was diluted x10 and the result was 9154 iu/ml. On (b)(6) 2015, a new sample was obtained and the result from a serum sample was 1115 iu/ml. The sample was diluted x100 and the result was 13402 iu/ml. The results from a plasma sample were 1192 iu/ml. The sample was diluted x100 and the result was 13998 iu/ml. It is not known if the patient was adversely affected. No adverse event was reported. The e602 analyzer serial number was not provided. The sample from (b)(6) 2015 was sent in for investigation. The sample was sent to an external laboratory and the fluorescent enzyme immunoassay (feia) ige result was 2803 iu/ml. On (b)(6) 2015, a sample from a different patient was tested for ige ii and the result was approximately 2500 iu/ml. This patient's sample was sent to the investigation unit as a reference value. No further information is available about this patient. The sample was sent to an external laboratory and the feia ige result diluted x10 was 7004 iu/ml.
Patient Sequence No: 1, Text Type: D, B5
[33719854]
The customer provided the patient samples in question and the reference sample for investigation. It was determined the patient samples contain anti-ige antibodies that aggregate with the ige molecules. This interference is addressed in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04579 |
| MDR Report Key | 5233423 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-18 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-10-13 |
| Date Mfgr Received | 2015-11-05 |
| Date Added to Maude | 2015-11-18 |
| 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 | 2015-11-18 |
| 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 | 2015-11-18 |