MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-16 for PFA-100 SYSTEM 10444868 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[114013196]
The customer contacted a siemens customer care center (ccc) and reported that they obtained elevated col/epi and col/adp results on patient samples and quality controls (qcs). The customer indicated that the error message "maximum test time exceeded" was triggered by the system. The customer reported an incident where they obtained different results on control donors, depending on the cuvette position used to process the sample. Siemens is investigating the issue. Mdrs 9610806-2018-00058, 9610806-2018-00059, 9610806-2018-00060, 9610806-2018-00061, 9610806-2018-00062, 9610806-2018-00063, 9610806-2018-00064, 9610806-2018-00065, 9610806-2018-00066, 9610806-2018-00067, 9610806-2018-00068, 9610806-2018-00069, 9610806-2018-00070, 9610806-2018-00071, and 9610806-2018-00072 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[114013197]
The customer reported that elevated collagen/ epinephrine (col/epi) and collagen/ adenosine-5'-diphosphate (col/adp) results were obtained on multiple patient samples on the pfa-100 system for several days. The elevated results were reported to the physician(s) and some physician(s) questioned the elevated results. It is unknown if the results provided by the customer were discordant and the results reported to the physician(s) are unknown. The customer did not provide the correct results for the patients impacted and reported that they did not provide correct results to the physician(s). There are no known reports of patient intervention or adverse health consequences due to elevated col/epi and col/adp results obtained on the patient samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00073 |
| MDR Report Key | 7689189 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-16 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-07-12 |
| Date Added to Maude | 2018-07-16 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | REGISTRATION NUMBER:3003601075 AM KRONBERGER HANG 3 |
| Manufacturer City | SCHWALBACH 65824 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFA-100 SYSTEM |
| Generic Name | PFA-100 SYSTEM |
| Product Code | JOZ |
| Date Received | 2018-07-16 |
| Model Number | PFA-100 SYSTEM |
| Catalog Number | 10444868 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-16 |