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 2018-07-20 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[114540109]
The customer contacted a siemens customer care center (ccc). The customer determined that both samples were pale yellow and clear and that the samples tubes were correctly filled. The customer indicated that the syringes, primes and pipettors on the system were recovering acceptably. They also reported that they ran a validation kit on the system, which recovered acceptably. There was no recurrence of this issue with other samples and siemens determined that the sample integrity and tube type were acceptable. A siemens customer service engineer (cse) was dispatched to the customer's site. As per the customer's request, the cse proactively replaced and aligned the reagent and sample probes and calibrated the piston pumps and reagent probe temperature. The customer informed the cse that the flagged results were produced as a result of improper sample centrifugation. Siemens further investigated the event and determined that there was no system or reagent malfunction. Siemens determined that the results were flagged appropriately and that quality controls (qcs) were within acceptable ranges on the day of the event. Low fibrinogen, clots in the sample, or a clogged sample probe potentially caused the flags to be triggered on the affected sample. Inadequate mixing, centrifugation and other mishandling of the sample cannot be ruled out as contributing factors to the flagged results. As per the "evaluation and checking methods for interpretation of measurement curves on the bcs system/bcs xp system" bulletin, results flagged with "measurement curve without reaction" errors are not to be reported as greater than or less than the reporting limit. Siemens determined the customer incorrectly reported the results and did not adequately follow the instructions documented in the bulletin. Siemens educated the customer on how to review reaction curves and informed the customer that the results obtained on the affected sample were not reportable. The system is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[114540110]
A flagged prothrombin time (pt) result of "no reaction" was obtained on a patient sample on a bcs xp system. The sample was repeated twice, in extended time, on the same system, resulting in "no reaction". The customer believed that the patient recovery was >200 seconds (>19 international normalized ratio [inr]) from the results obtained on the bcs xp system and reported these results to the physician(s), who questioned the results. The sample was rerun on an alternate non-siemens system, using the same dade innovin reagent lot, recovering in a result of 10. 1 seconds. The sample was re-centrifuged and re-run on the initial system, recovering lower than the reported result. The result obtained on the initial system, after the sample was re-centrifuged, was reported to the physician(s). The patient was redrawn and the new sample was run on the initial bcs xp system; a pt result of 10. 8 seconds was obtained on the new sample. This result was also reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated pt and pt inr results reported on the patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00074 |
| MDR Report Key | 7705720 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-20 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-06-25 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-07-20 |
| 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 | 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 | AM KRONBERGER HANG 3 REGISTRATION NUMBER:3003601075 |
| 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 | BCS XP SYSTEM |
| Generic Name | BCS XP SYSTEM |
| Product Code | GKP |
| Date Received | 2018-07-20 |
| Model Number | BCS XP SYSTEM |
| Catalog Number | 10459330 |
| 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- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-20 |