MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-10-15 for ELECSYS IGE II 04827031190 manufactured by Roche Diagnostics.
[3775244]
The customer alleged they received questionable immunoglobulin e (ige) results for one patient on their e602 analyzer. The specific date of this event was requested but not provided. The patient's initial ige result was 600 iu/ml and it was reported outside the laboratory. The physician thought the result was too low compared to the patient's condition. The first repeat result was 600 iu/ml. The sample was then diluted 1:10, and the result was >2500 iu/ml. The sample was then diluted 1:100, and the result was >2500 iu/ml. The sample was finally diluted 1:1000, and the result was 240000 iu/ml. It was unknown which repeat results were reported to the physician. There were no deaths, injuries, illnesses, or deteriorations in health associated with the erroneous result. No adverse event has been reported. The ige reagent lot number was 168340 and the expiration date was 12/30/2013.
Patient Sequence No: 1, Text Type: D, B5
[11122570]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[11248028]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15947141]
A specific root cause could not be determined with the information provided. Additional details were requested but not provided. Based upon the information provided, the sample diluted 1:1000 gave a result of 240000 iu/ml. It is known that samples above a concentration of 50000 iu/ml may be affected by a high does hook effect. This limitation is documented in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-06312 |
| MDR Report Key | 3410556 |
| Report Source | 01,05,06 |
| Date Received | 2013-10-15 |
| Date of Report | 2013-10-31 |
| Date of Event | 2013-10-08 |
| Date Mfgr Received | 2013-10-08 |
| Date Added to Maude | 2013-10-15 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 |
| Generic Name | RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)21 |
| Product Code | JHR |
| Date Received | 2013-10-15 |
| Model Number | NA |
| Catalog Number | 04827031190 |
| Lot Number | 168340 |
| ID Number | NA |
| Device Expiration Date | 2013-12-30 |
| 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 | 2013-10-15 |