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 2016-06-30 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219 SMN 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[48514872]
The cause of the shifted high aptt results is unknown. Siemens evaluated the data. The shift high was observed in some patients, not all patients. Actual patient values and repeat testing was requested, however, was not provided by the customer to determine if values were truly erroneous. They observed a shift upward in some patient recovery where they expect normal values since (b)(6) 2016. They did not observe a shift upward in control recovery. The issue resolved with a new shipment of the lot of reagent that had been in use at the account since (b)(6) 2015. The account believes this was resolved with a new shipment of reagent. No further evaluation of the devices is required.
Patient Sequence No: 1, Text Type: N, H10
[48514873]
The account noted a shift upward in activated ptt (aptt) patient results with the actin fsl reagent lot 547448 on the ca-7000 instrument over a period since (b)(6) 2016. No shift in qc results was noted during the same period. During the period patient results were reported to physicians. There is no indication that patient treatment was altered or prescribed on the basis of falsely elevated aptt results. There is no indication of adverse health consequences to patients on the basis of the falsely elevated aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00021 |
| MDR Report Key | 5761189 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-30 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-04-01 |
| Date Mfgr Received | 2016-05-31 |
| Device Manufacturer Date | 2014-11-26 |
| Date Added to Maude | 2016-06-30 |
| 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 | 3 |
| Event Location | 3 |
| 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 | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2016-06-30 |
| Catalog Number | B4219 SMN 10445714 |
| Lot Number | 547448 |
| Device Expiration Date | 2016-11-03 |
| 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 | 1. Congenital Not Applicablenomaly | 2016-06-30 |