MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-06 for ELECSYS CALCITONIN IMMUNOASSAY 06445853190 manufactured by Roche Diagnostics.
[69368425]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69368426]
The customer stated that they received erroneous results for 5 samples from the same patient tested for the elecsys calcitonin immunoassay (calc) on a cobas e 411 immunoassay analyzer (e411). All erroneous results were reported outside of the laboratory to a clinician. The results were said to be discrepant to the clinical condition of the patient and findings on imaging. On (b)(6) 2017, the patient had a calc result of 22400 pg/ml. On (b)(6) 2017, the patient had a calc result of 22810 pg/ml. On (b)(6) 2017, the patient had a calc result of 43226 pg/ml. On (b)(6) 2017, the patient had a calc result of 34040 pg/ml. On (b)(6) 2017, the patient had a calc result of 33653 pg/ml. Imaging of the patient showed no increase in tumoral mass. The patient was not adversely affected. The e411 analyzer serial number was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[69979479]
It was stated on (b)(6) 2017 that the condition of the patient has stabilized and the calc concentration has also stabilized.
Patient Sequence No: 1, Text Type: N, H10
[73589574]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. No samples from the patient were available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00468 |
| MDR Report Key | 6379821 |
| Date Received | 2017-03-06 |
| Date of Report | 2017-04-24 |
| Date of Event | 2017-02-06 |
| Date Mfgr Received | 2017-02-14 |
| Date Added to Maude | 2017-03-06 |
| 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 | 3 |
| Brand Name | ELECSYS CALCITONIN IMMUNOASSAY |
| Generic Name | CALCITONIN TEST SYSTEM |
| Product Code | JKR |
| Date Received | 2017-03-06 |
| Model Number | NA |
| Catalog Number | 06445853190 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2017-03-06 |