MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-28 for DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100 B4170-1 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[71219445]
The customer contacted siemens customer care center (ccc) to report the event on the pfa-100 system. The customer stated that she proactively had herself drawn as a normal donor and ran her sample in both a and b positions of the pfa-100 platelet function analyzer to verify epi results. The epi results that were generated were within normal range: position a - 115 seconds and position b - 127 seconds. The cause of the event of the discordant high results for collagen epinephrine (epi) and collagen adenosine diphosphate (adp) is unknown.
Patient Sequence No: 1, Text Type: N, H10
[71219446]
Discordant high results of >300 seconds (closure time) for collagen epinephrine (epi) and collagen adenosine diphosphate (adp) were generated in position a of the pfa-100 platelet function analyzer. Neither result was reported to the physician. The customer range for epi is 80-184 seconds and the customer range for adp is 56-102 seconds. The same sample was repeated on the same instrument 15 minutes later and an epi result of 108 seconds was generated (repeat 1) in position a and >300 seconds in position b. Neither result was reported. A new sample was repeated on the same instrument and an epi result of >300 seconds in position a and 117 seconds in position b were generated (repeat 2). The same sample from repeat 2 was tested again on the same instrument and an epi result of >292 seconds with an insufficient sample error was generated in position a (repeat 3). More sample was added to the cartridge (1000ul) and an epi result of >300 seconds was generated in position a and 124 seconds in position b. None of these epi results were reported to the physician. The patient sample was sent out for confirmation testing to a reference lab with a pfa-100 platelet function analyzer and a result of >300 seconds was generated for epi and 103 seconds for adp. These results were reported to the physician and accepted. There was no known impact or adverse health consequence to the patient due to the discordant high epi and adp results as the initial results were not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00044 |
| MDR Report Key | 6438552 |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-28 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-03-02 |
| Date Added to Maude | 2017-03-28 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100 |
| Generic Name | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100 |
| Product Code | JOZ |
| Date Received | 2017-03-28 |
| Model Number | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100 |
| Catalog Number | B4170-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 STRASSE 76 MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-28 |