MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for ELECSYS CALCITONIN IMMUNOASSAY 06445853190 manufactured by Roche Diagnostics.
[145224102]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[145224103]
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys calcitonin immunoassay (calcitonin) on a cobas e 411 immunoassay analyzer. The initial result from the 411 analyzer was 3. 05 pg/ml. This result was reported outside of the laboratory. On (b)(6) 2019 the sample was repeated on the e411 analyzer with a result of 2. 89 pg/ml. The sample was also run twice by the elisa biomerica biochemmak method and the results were both > 200 pg/ml. The sample was sent to 2 other external laboratories where the result from the immulite method was "within the normal range" and the result from a different elisa method was > 200 pg/ml. There was no allegation that an adverse event occurred. The e411 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01787 |
| MDR Report Key | 8607197 |
| Date Received | 2019-05-14 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | ELECSYS CALCITONIN IMMUNOASSAY |
| Generic Name | CALCITONIN TEST SYSTEM |
| Product Code | JKR |
| Date Received | 2019-05-14 |
| Model Number | CALCITONIN |
| Catalog Number | 06445853190 |
| Lot Number | 33757800 |
| Device Expiration Date | 2019-10-31 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |