MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-08-08 for DIMENSION CLINICAL CHEMISTRY SYSTEM DF88 manufactured by Siemens Healthcare Diagnostics, Inc..
[895320]
A falsely elevated acetaminophen result was obtained on a patient sample. The result was reported to the physician. The sample was repeated and a negative result was obtained. The patient was given mucamyst and admitted to icu. There was no report of adverse health consequences as a result of the falsely elevated aceaminophen result.
Patient Sequence No: 1, Text Type: D, B5
[8108362]
Analysis of the instrument and instrument data indicate that the cause for the falsely elevated acetaminophen result is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2008-00074 |
| MDR Report Key | 1113385 |
| Report Source | 05,06 |
| Date Received | 2008-08-08 |
| Date of Report | 2008-07-31 |
| Date of Event | 2008-07-18 |
| Date Mfgr Received | 2008-08-01 |
| Device Manufacturer Date | 2008-03-04 |
| Date Added to Maude | 2009-06-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAROLYN CHASTAIN |
| Manufacturer Street | P.O. BOX 6101 M/S 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318789 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC |
| Manufacturer Street | P.O. BOX 6101 |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION CLINICAL CHEMISTRY SYSTEM |
| Generic Name | ACTM FLEX REAGENT CARTRIDGE |
| Product Code | LDP |
| Date Received | 2008-08-08 |
| Model Number | NA |
| Catalog Number | DF88 |
| Lot Number | CA9063 |
| ID Number | NA |
| Device Expiration Date | 2009-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | P.O. BOX 6101 NEWARK DE 19714610 US 19714 6101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-08 |