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 2018-03-14 for LA 1 SCREENING REAGENT 10461887 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[102469321]
The customer contacted siemens and reported that they obtained a discordant, falsely elevated lupus anticoagulants (la) 1 screening reagent clotting time patient result on a bcs xp system using the la 1 screening reagent. The customer reported that they receive frozen samples. Upon receipt, the customer thaws the samples in a 37 degrees water bath for 5-10 minutes prior to placing it on a rocker. The sample is then rocked for 5-20 minutes. The customer also reported that they conduct a medical review of abnormal results by comparing the abnormal result to results obtained on other parameters for the patient. A siemens headquarters support center (hsc) specialist contacted the customer to investigate the cause of the event. The customer reported that their lab has 4 bcs xp systems and independent reagent vials are loaded into each system. Siemens further reviewed the backup files and determined that quality controls recovered within expected ranges prior to running the affected patient samples on (b)(6)2018. Siemens determined that the samples were run with pooled vials of reagent, which gradually decreased with time (as expected). The error logs contained implausible volume detection errors, but the volume of the reagent and sample id (b)(6) were not impacted. Siemens determined that there was no indication of a system or reagent malfunction that contributed to the discordant, falsely elevated la 1 screening reagent clotting time result. The cause of the event is unknown. A siemens field service engineer (fse) was dispatched to the customer's site for rotor handler and rack transfer errors on 15-feb-2018. The hsc specialist determined that this service was unrelated to this event. The systems and reagent are performing according to specifications. No further evaluation of these systems and reagent is required. Mdr 9610806-2018-00032 and mdr 9610806-2018-00033 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[102469322]
A discordant, falsely elevated lupus anticoagulants (la) 1 screening reagent clotting time result was obtained on a patient sample on a bcs xp system (serial number (sn) (b)(4)) using the la 1 screening reagent. Due to the elevated result, the sample was tested for la 2 confirmation reagent clotting time and a ratio was calculated from these results. Based on the lab's ranges, the ratio signified that the patient was positive for la. None of these results were reported to the physician(s). The same sample was rerun on an alternate bcs xp system (sn (b)(4)), resulting in a lower la 1 screening reagent clotting time result. The sample was tested for la 2 confirmation reagent clotting time and a ratio was calculated from these results. The ratio of 0. 9 was reported to the physician(s), indicating that the patient was negative for la and this was consistent with the patient's clinical picture. The sample was frozen and rerun on (b)(6) 2018 on an alternate bcs xp system (sn (b)(4)), resulting in a lower la 1 screening reagent clotting time result than the initial result. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated la 1 screening reagent clotting time result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00034 |
| MDR Report Key | 7339663 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-14 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-02-24 |
| Date Mfgr Received | 2018-02-28 |
| Date Added to Maude | 2018-03-14 |
| 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 | DSRV, INC. |
| Manufacturer Street | REGISTRATION #: 3004737529 330 WATERLOO VALLEY RD STE 200 |
| Manufacturer City | MOUNT OLIVE NJ 07828 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LA 1 SCREENING REAGENT |
| Generic Name | LA 1 SCREENING REAGENT |
| Product Code | GIR |
| Date Received | 2018-03-14 |
| Model Number | LA 1 SCREENING REAGENT |
| Catalog Number | 10461887 |
| Lot Number | 549936A |
| Device Expiration Date | 2018-11-10 |
| 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 | 2018-03-14 |