MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-21 for MICROALBUMIN_2 REAGENTS (UALB) manufactured by Siemens Healthcare Diagnostics Inc..
[63325882]
The customer contacted the siemens customer care center (ccc). The quality controls were within range on the day of the event. The customer checked the sample and noted large bubbles. The customer then poured primary tube into a secondary cup and repeated the samples. A siemens headquarter support center (hsc) reviewed the instrument data and observed that the reaction curves are consistent with an interference in the patient samples. The cause of the discordant, falsely elevated ualb_2 results on one patient sample is due to sample specific interference. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[63325883]
Discordant, falsely elevated urine microalbumin 2 (ualb_2) results were obtained on one patient sample on two advia 2400 instruments (serial numbers (b)(4)). The discordant results were not reported to the physician(s). After auto-dilutions, the sample was rerun on both instruments, resulting lower. The customer re-spun the sample, performed manual dilution and reran the sample on advia 2400 instrument ((b)(4)), resulting lower than the initial discordant results. The corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ualb_2 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00791 |
| MDR Report Key | 6195153 |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-11-24 |
| Date Mfgr Received | 2016-11-25 |
| Date Added to Maude | 2016-12-21 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | RANDOX LABORATORIES LTD. |
| Manufacturer Street | 55 DIAMOND ROAD |
| Manufacturer City | CRUMLIN, CO. ANTRIM BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MICROALBUMIN_2 REAGENTS (UALB) |
| Generic Name | MICROALBUMIN_2 REAGENTS (UALB) |
| Product Code | JIR |
| Date Received | 2016-12-21 |
| Model Number | MICROALBUMIN_2 REAGENTS (UALB) |
| Lot Number | 373185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-21 |