MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-11 for PCP_2 REAGENT PCP_2 REAGENTS 10378764 manufactured by Siemens Healthcare Diagnostics Inc..
[17971696]
Seven false positive results for phencyclidine (pcp) were obtained on an advia 1800 instrument. The results were reported to the physicians and were questioned. The same samples were rerun on an alternative manual method and negative results were obtained. There are no known reports of patient intervention or adverse health consequences due to the discordant pcp results.
Patient Sequence No: 1, Text Type: D, B5
[18175385]
Siemens investigated the event. The database of the instrument was investigated by the technical application specialist (tas). The cause of the discordant results was incorrect calibration. The customer changed the lot of the reagent without performing a full two-point calibration. The results of the calibration were atypical. The results of the quality control were also atypical. The instructions for use (ifu) states: " the pcp method provides only a preliminary test result. The user must use more specific alternative methods to obtain a confirmed analytical result. Siemens healthcare diagnostics recommends using the gaschromatography/mass spectroscopy (gc/ms) confirmatory method. " the instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00333 |
| MDR Report Key | 2784226 |
| Report Source | 05,06 |
| Date Received | 2012-10-11 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-05-15 |
| Date Mfgr Received | 2012-10-03 |
| Date Added to Maude | 2013-01-24 |
| 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 | 0 |
| Manufacturer Contact | MR. RANJAN SADARANGANI |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242868 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PCP_2 REAGENT |
| Generic Name | ENZYME IMMUNOASSAY, PHENCYCLIDINE |
| Product Code | LCM |
| Date Received | 2012-10-11 |
| Model Number | PCP_2 REAGENTS |
| Catalog Number | 10378764 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-11 |