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 2017-05-15 for PATHROMTIN SL 10446066 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[75321471]
Siemens healthcare diagnostic inc (siemens) regional support center (rsc) and technical support center (tsc) investigated the cause of the discordant high aptt result on the sysmex cs-5100 system. The rsc and tsc analyzed the cs-5100 system back up files. The aptt results changed over time for both patient samples, independent of the day of testing. This portrays that there is a sample peculiarity which can be minimized by either re-centrifugation, day 1, or vigorously mixing, day 2. Therefore, a sample peculiarity and a pre-analytical issue/handling issue potentially contributed to the discordant result. Since the aptt result for this patient sample is time-dependent and no other known discordant results were obtained from other patient samples, sample quality is the cause of the discordant result. There is no evidence for potential systemic performing issues of either the instrument or reagent. The device is performing according to specifications. The other reagent used to run the patient sample was actin fs: lot number: 538513, catalog number: 10445712, expiration date (mm/dd/yyyy) : 03/14/2018. (b)(4). The other pathromtin sl reagent lot used to the run the patient sample has: lot number: 536694a, catalog number: 10484200, expiration date (mm/dd/yyyy): 06/12/2018, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75321472]
A discordant, falsely elevated activated partial thromboplastin time (aptt) result (118. 9 seconds) was obtained on a patient sample on the sysmex cs-5100 system using pathromtin sl (lot 536694b). The discordant, falsely elevated aptt result was not reported to the physician. The same sample was repeated on the same cs-5100 system using the same reagent lot three additional times and resulted in 98. 4 seconds, 82. 1 seconds, 77. 7 seconds. These results were not reported to the physician. The same sample was inspected for clots, re-centrifuged and re-ran on the same cs-5100 system using the same reagent lot. A result of 71. 7 seconds was obtained for this re-centrifuged sample for aptt and aptt extended. The same sample was also run on a stago (non-siemens) system at another lab and resulted in 41 seconds. Another blood sample from the same patient was run on the same sysmex cs-5100 system using a different reagent lot (536694a). A result of 106. 9 seconds was obtained. The re-drawn blood sample was re-run on the cs-5100 system using actin fs reagent and resulted in 27. 6 seconds. The re-drawn blood sample was vigorously mixed and repeated again using a new pathromtin sl vial (lot 536694a) and the following results were obtained: 81. 2 seconds for aptt and 81. 3 seconds for aptt extended. The re-drawn blood sample was measured at another lab on a cs-2100 system with pathromtin sl (lot 536694) and 2 results were obtained (62. 0 seconds and 61. 2 seconds). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt results.
Patient Sequence No: 1, Text Type: D, B5
[80149326]
Siemens healthcare diagnostics (siemens) filed the initial mdr (9610806-2017-00055) on may 15, 2017. On may 16, 2017, additional information: siemens field service engineer (fse) was dispatched to the customer site to determine the cause of the (b)(6) elevated activated partial thromboplastin time (aptt) results and found no issues. Evaluation codes has been updated to reflect this additional information and additional information regarding the age of the patient is updated. Relevant tests/lab data has been updated to reflect the additional information provided on may 16, 2017 regarding the other aptt results obtained on the re-drawn patient sample. Other relevant history has been updated to reflect that the (b)(6) biopsy was not delayed due to the (b)(6) result since the correct result using actin fs was reported to the physician. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2017-00055 |
| MDR Report Key | 6567304 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-15 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-05-15 |
| 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 | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242495 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATHROMTIN SL |
| Generic Name | PATHROMTIN SL |
| Product Code | GFO |
| Date Received | 2017-05-15 |
| Model Number | PATHROMTIN SL |
| Catalog Number | 10446066 |
| Lot Number | 536694B |
| Device Expiration Date | 2018-06-12 |
| 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 | 2017-05-15 |