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.
[102600388]
A siemens headquarters support center (hsc) specialist contacted the customer to investigate the cause of the 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 did not observe any system flag when the discordant result was obtained. The customer received 5 sample tubes from this patient and was not able to correlate the result to a specific sample collection tube and time. 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. The hsc specialist was not able to identify the data for this patient in the system's backup files. The hsc specialist determined that the cause of the discordant, falsely elevated la 1 screening reagent clotting time result was potentially due to a sample handling or collection issue. The cause of the discordant result on this patient cannot be determined since the customer did not want to further investigate this sample. The systems and reagent are performing according to specifications. No further evaluation of these systems and reagent is required. Mdr 9610806-2018-00033 and mdr 9610806-2018-00034 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[102600389]
A discordant, falsely elevated lupus anticoagulants (la) 1 screening reagent clotting time result was obtained on a patient sample on a bcs xp system using the la 1 screening reagent. Due to this, 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). A sample from the same patient was run on an alternate bcs xp system and lower la 1 screening reagent clotting time and la 2 confirmation clotting time results were obtained on the patient sample. It is unknown if the initial results and repeat results were obtained using the same sample. The result of 39. 3 seconds was reported to the physician(s), who did not question the 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 | 9610806-2018-00032 |
| MDR Report Key | 7339668 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-14 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-02-06 |
| Date Mfgr Received | 2018-02-15 |
| 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 |