MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-17 for N ANTISERUM TO HUMAN-IG/L-CHAIN, K TYPE 10446594 (SEE SECTION H10) manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[75513628]
The siemens healthcare diagnostics inc. (siemens) headquarters support center (hsc) analyzed data files to determine the cause of the discordant low kapu result on the bn prospec system and found no issues. The initial patient sample was re-run on the bn prospec system and a result that matched the patient's clinical picture was obtained. The cause of the event is unknown. It is possible that the discordant result was caused by antigen excess in the patient sample. The instructions for use (ifu) states that "urine specimens with highly elevated immunoglobulin/l-chain concentrations may yield false low results. In such suspected cases, e. G. Due to the clinical findings or other laboratory data, it is recommended that the sample should be retested using a higher sample dilution. " the instrument is performing according to specifications. No further evaluation of this device is required. The reagent that is marketed in the us is a bulk identical to the reagent described. The reagent marketed in the us is smn: (b)(4) and gtin: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75513629]
A discordant, falsely depressed n antiserum to human ig/l-chain, k type (kapu) result was obtained on a patient sample on the bn prospec system. The discordant result was obtained using a 1:1 dilution and resulted in 38. 6 mg/dl. This result was reported to the physician, who questioned the result. The same patient sample was re-run at a higher dilution of 1:5 and the result recovered >2,200 mg/l. The bn prospec system initiated a third measurement with an auto-dilution factor of 1:1 and a result of 11,100 mg/l was obtained. The repeated result of 11,100 mg/l was reported to the physician. Quality control was within the normal ranges and no instrument errors were found with the bn prospec system during the event. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed kapu result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00056 |
| MDR Report Key | 6572191 |
| Date Received | 2017-05-17 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-04-21 |
| Date Added to Maude | 2017-05-17 |
| 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 | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242495 |
| 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 | 0 |
| Brand Name | N ANTISERUM TO HUMAN-IG/L-CHAIN, K TYPE |
| Generic Name | N ANTISERUM TO HUMAN-IG/L-CHAIN, K TYPE |
| Product Code | DFH |
| Date Received | 2017-05-17 |
| Model Number | N ANTISERUM TO HUMAN-IG/L-CHAIN, K TYPE |
| Catalog Number | 10446594 (SEE SECTION H10) |
| Lot Number | 122187 |
| Device Expiration Date | 2019-07-19 |
| 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 | 2017-05-17 |