MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-06 for COAGULATION FACTOR IX DEFICIENT PLASMA OTXX manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[18728174]
Falsely elevated coagulation factor ix (fix) results were reported on a patient sample. The result was reported to the physician with no indication that results were questioned. At a later date when the account became aware of failures on cap survey samples, it was determined that the result was falsely elevated. It is unknown if the patient was treated on the basis of the reported falsely elevated fix result. However, it is likely that the physician questioned the reported 1:40 result due to the accompanying "possible inhibitor" flag. There is no report of adverse outcome to the patient as a result of the initial falsely elevated fix result.
Patient Sequence No: 1, Text Type: D, B5
[18767462]
The cause of the falsely elevated fix result is user error. The customer went live with the fix assay in (b)(6) 2013. The assay is a user defined method which requires validation/verification by the customer. However, at the time of installation of the method, insufficient control material was available to perform validation/verification. The siemens technical assistance specialist assisted in the set-up of the user defined method by duplicating the defined method settings for the factor viii test but due to lack of patient samples at that time, the fix assay could not be verified. The bcs(r) xp system instruction manual in the laboratory-specific definitions and settings section states: it is the responsibility of the user to validate any modifications made to these instructions, instruments, reagents or software provided by dade behring. " the root cause was determined to be factor ix 1:20 and 1:40 assay definitions were linked incorrectly to factor ix 1:10 assay procedure. When the factor ix 1:20 and 1:40 assay was ordered, the analyzer ran the 1:10 dilution. The result factor was set correctly. Consequently, the incorrect raw values with the result factor applied cause the factor ix results for the three dilutions to appear to indicate the presence of an inhibitor. The results appear with the 1:20 and 1:40 results multiplied by the incorrect dilution factor and the results to be printed with the "possible inhibitor" comment. The account contacted the physician upon becoming aware of the error in setting and has confirmed, "there was no ill effect on the treatment of these patients based on the factor ix results we originally reported. " the account has corrected the assay setting and validated the corrected settings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2013-00035 |
| MDR Report Key | 3504474 |
| Report Source | 05,06 |
| Date Received | 2013-12-06 |
| Date of Report | 2013-11-07 |
| Date of Event | 2013-08-26 |
| Date Mfgr Received | 2013-11-07 |
| Device Manufacturer Date | 2012-05-11 |
| Date Added to Maude | 2014-03-18 |
| 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 | 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 | COAGULATION FACTOR IX DEFICIENT PLASMA |
| Generic Name | COAGULATION FACTOR IX DEFICIENT PLASMA |
| Product Code | GJT |
| Date Received | 2013-12-06 |
| Catalog Number | OTXX |
| Lot Number | 500865 |
| Device Expiration Date | 2014-03-06 |
| 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 | 2013-12-06 |