MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-29 for BERICHROM(R) HEPARIN OWLD115 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[4091174]
Discordant low heparin results were obtained on patient samples. The results were not reported to the physician. The samples were repeated with freshly prepared reagents and higher results were obtained in better accord with patient history. The repeat results were reported. Patient treatment or diagnosis was not altered on the basis of the discordant low patient heparin results. There was no report of adverse health consequences as a result of the discordant low patient heparin results.
Patient Sequence No: 1, Text Type: D, B5
[11489995]
The cause of the discordant low heparin results is user error. This event and other similar occurrences at the same account with the same reagent system were instances of improper reagent handling by the same technologist. The supervisor at the account does not suspect a product issue. The supervisor at the account committed to retraining of the technologist on proper reagent preparation and handling. In each occurence the issue was resolved with proper preparation of fresh reagents. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2014-00009 |
| MDR Report Key | 3596348 |
| Report Source | 05,06 |
| Date Received | 2014-01-29 |
| Date of Report | 2004-01-03 |
| Date of Event | 2014-01-03 |
| Date Mfgr Received | 2014-01-03 |
| Device Manufacturer Date | 2013-08-09 |
| Date Added to Maude | 2014-04-23 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERICHROM(R) HEPARIN |
| Generic Name | BERICHROM(R) HEPARIN |
| Product Code | KFF |
| Date Received | 2014-01-29 |
| Catalog Number | OWLD115 |
| Lot Number | 43091 |
| Device Expiration Date | 2016-05-27 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-29 |