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 2017-09-01 for N ANTISERUM TO HUMAN IGM 10446303 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[85297296]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer site to determine the cause of the different igm results obtained the patient sample on the bn ii system and found no issues. Similar results were obtained on both systems and the internal quality controls recovered within range, indicating a sample issue. The customer agreed that this issue is sample specific. The customer reported that they have not received any complaints from any physicians. The customer powered down the system since the original patient samples were run and the kinetics and original patient sample were not available for further investigation. The instruments and reagents are performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[85297297]
A flagged high immunoglobulin m (igm) result was obtained on a patient sample on the bn ii system. The same patient sample was diluted using multiple dilution ratios and run on the same bn ii system. Different igm results were obtained on these samples and the results were dilution ratio dependent. The same patient sample was respun and run with multiple dilutions on an alternate bn ii system. The results obtained on the alternate bn ii system matched the results obtained on the original system. An igm result of 508. 0 mg/dl was reported to the physician. The customer indicated that the correct result for this patient is unknown since they do not have the patient's clinical history. There are no known reports of patient intervention or adverse health consequences due to the flagged high igm result on this patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00096 |
| MDR Report Key | 6840149 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-01 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-09-01 |
| 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 | 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 IGM |
| Generic Name | N ANTISERUM TO HUMAN IGM |
| Product Code | CFN |
| Date Received | 2017-09-01 |
| Model Number | N ANTISERUM TO HUMAN IGM |
| Catalog Number | 10446303 |
| Lot Number | 153226F |
| Device Expiration Date | 2019-02-19 |
| 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 | 2017-09-01 |