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 2018-01-26 for ELECSYS BRAHMS PCT 05056888003 manufactured by Roche Diagnostics.
[98588072]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[98588073]
The customer complained of high results for 1 patient tested for elecsys brahms pct (pct) that did not correspond to the patient? S clinical picture. The patient? S pct results have been consistently over 100 ng/ml. The results have been reported outside of the laboratory where the high results were questioned by the medical doctor. The high results were questioned as the patient does not have sepsis and the patient? S crp results were low. A high pct result can also be caused by medullary thyroid carcinoma (mtc). This disease has been ruled out for the patient by measuring calcitonin results which were low. There was no allegation that an adverse event occurred. The instrument type and serial number were not provided.
Patient Sequence No: 1, Text Type: D, B5
[132930832]
Lot number and expiration date were updated. The instrument was a cobas e 411 immunoassay analyzer with a serial number of (b)(4). A new sample was obtained on (b)(6) 2018 and the pct result was 91. 1 ng/ml at the customer site. It was clarified that when attempts were made to test this patient prior to the result on (b)(6) 2018, the result on (b)(6) 2018 was >100 ng/ml with a data flag. The patient has been in the hospital since (b)(6) 2017 due to severe pancreatitis including septic shock as well as organ failure. Pct was high from the beginning with elecsys pct values always >100 ng/ml with a data flag. Crp was also high, but since the last week in (b)(6) 2018, it has decreased to 30 mg/l. Since the last week in (b)(6) 2018, the patient is awake and mobile, but is still hospitalized; the patient is not receiving catecholamines any longer. The patient has deliric syndrome ("delirantes syndrome") including positive blood cultures which do not correlate with the clinical picture since the patient shows no fever. The patient does suffer from ongoing intestinal fistulas. The high pct values triggered a change in treatment during the time the patient was suffering from clinical septic shock. The pancreatitis was treated conservatively for awhile and the first operations started at the end of (b)(6) 2017. These operations led to the intestinal fistulas.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00250 |
| MDR Report Key | 7221964 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-26 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-01-07 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2018-01-26 |
| 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 BRAHMS PCT |
| Generic Name | DEVICE TO DETECT AND MEASURE PROCALCITONIN (PCT) IN HUMAN CLINICAL SPECIMENS |
| Product Code | PMT |
| Date Received | 2018-01-26 |
| Model Number | NA |
| Catalog Number | 05056888003 |
| Lot Number | 273163 |
| ID Number | NA |
| Device Expiration Date | 2018-10-31 |
| 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 | 2018-01-26 |