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 2015-01-09 for ELECSYS IGE II IMMUNOASSAY 04827031190 manufactured by Roche Diagnostics.
[5368173]
The customer reported that they received erroneous results for one patient sample tested for immunoglobulin e (ige). The customer stated that they "understand that the measurements of this sample were affected by prozone. " the sample initially resulted as 2300 iu/ml. The patient's record showed that the patient had a previous result of 69000 iu/ml. It was also noted that a previous sample from this same patient tested on (b)(6) 2014 had an ige result of 2289 iu/ml. A value of 2939 iu/ml which was said to be an "original" was also provided. The sample in question was then diluted multiple times using different dilution ratios on (b)(6) 2014. All results from the dilutions, except for four, were greater than the measuring range of the assay. The following dilution information and results were provided for the four samples that did not measure outside of the measuring range of the assay. The sample was diluted "0/10" and gave a result of 0. 388 iu/ml. A dilution with a ratio of "2/10" resulted as 2312 iu/ml. A dilution with a ratio of "10/10" resulted as 2362 iu/ml. A dilution with a ratio of 1:100 resulted with a raw value of 616. 1 iu/ml which was calculated to be a value of 61610 iu/ml. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. The patient was not adversely affected. The sample was tested on an e601 analyzer. The serial number of the analyzer was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[12733505]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[12970794]
The sample was tested on e601 analyzer serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[17699728]
It was determined that the analyzer in question had not been calibrated since (b)(6) 2014. Based on this information, it is assumed that the reported erroneous results would be above the measuring range when measured using a correctly calibrated analyzer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-00192 |
| MDR Report Key | 4405030 |
| Report Source | 01,05,06 |
| Date Received | 2015-01-09 |
| Date of Report | 2015-01-23 |
| Date of Event | 2014-12-16 |
| Date Mfgr Received | 2014-12-17 |
| Date Added to Maude | 2015-01-09 |
| 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 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 | 2015-01-09 |
| Model Number | NA |
| Catalog Number | 04827031190 |
| Lot Number | 175624 |
| ID Number | NA |
| Device Expiration Date | 2015-07-30 |
| 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 | 2015-01-09 |