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 2019-01-09 for ELECSYS ACTH TEST SYSTEM 07026684190 manufactured by Roche Diagnostics.
[132510199]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[132510200]
The customer complained of questionable elecsys acth test system results for 1 patient sample on a cobas 8000 e 801 module compared to the aia (tosoh) method. On (b)(6) 2018 the patient had an acth result of 4. 3 pg/ml at a different hospital. The method was asked for but not provided. The result did not meet the clinical symptoms for the patient and the patient's hospital requested additional testing. On (b)(6) 2018 the acth result was 3. 32 pg/ml on the e 801. The acth result was 73. 7 pg/ml on the aia (tosoh) method. There were erroneous results reported outside of the laboratory. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00130 |
| MDR Report Key | 8231046 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-09 |
| Date of Report | 2019-03-20 |
| Date of Event | 2018-12-20 |
| Date Mfgr Received | 2018-12-27 |
| Date Added to Maude | 2019-01-09 |
| 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 | 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 ACTH TEST SYSTEM |
| Generic Name | ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM |
| Product Code | CKG |
| Date Received | 2019-01-09 |
| Model Number | ACTH |
| Catalog Number | 07026684190 |
| Lot Number | 345521 |
| 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 | 2019-01-09 |