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 2019-04-18 for N ANTISERUM TO HUMAN ALBUMIN 10446282 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[142666167]
The customer contacted a siemens customer care center (ccc) and reported that they observed a difference in albumin/csf results from two different dilutions on a patient sample on the atellica neph 630 system. Siemens analyzed the provided customer save data file. Siemens determined that there was no instrument or reagent malfunction. Albumin in serum and csf can also be analyzed using a single reference curve, provided that the appropriate sample dilution is selected manually. If the results obtained are outside the measuring range, the assay can be repeated using a higher or lower dilution of the sample as per the system's instruction manual. The customer diluted affected samples with nacl. The cause of the discordant albumin result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2019-00043 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[142666168]
Customer observed a difference between two diluted results from the same cerebral spinal fluid (csf) sample on the atellica neph 630 system using the n antiserum to albumin reagent (lot 153939b) on two separate dates. The original sample result was flagged for turbidity for immunoglobulin g (igg) and carried no flag for albumin. The initial albumin resulted in a value greater than the measuring range with an initial dilution of 1:5, the sample was repeated with a dilution of 1. 2 and yielded lower values. The same sample was repeated two days later using the same instrument and reagent in 1:2 manual dilution with sodium chloride (nacl), which resulted in a lower value. The customer did not report any of the results obtained for this sample to the physician because the correct result is unknown. There are no known reports of patient intervention or adverse event due to the elevated albumin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00044 |
| MDR Report Key | 8528750 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-18 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-04-26 |
| Date Added to Maude | 2019-04-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BENLEY SAINT-JEAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242398 |
| 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 | N ANTISERUM TO HUMAN ALBUMIN |
| Generic Name | N ANTISERUM TO HUMAN ALBUMIN |
| Product Code | DCF |
| Date Received | 2019-04-18 |
| Model Number | N ANTISERUM TO HUMAN ALBUMIN |
| Catalog Number | 10446282 |
| Lot Number | 153939B |
| 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 | 2019-04-18 |