MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-30 for DIMENSION (R) CLINICAL CHEMISTRY SYSTEM DF88 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[2275741]
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 admitted to the facility. There was no report of adverse health consequences as a result of the falsely elevated acetaminophen result.
Patient Sequence No: 1, Text Type: D, B5
[9492626]
Analysis of the instrument and instrument data indicate that the cause for the falsely elevated acetaminophen result is sample integrity. The dimension(r) flex(r) reagent cartridge acetominophen ifu states: "follow the instructions provided with your specimen collection device for use and processing. " and "specimens should be free of particulate matter". The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2011-00160 |
| MDR Report Key | 2352853 |
| Report Source | 05,06 |
| Date Received | 2011-11-30 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-11-04 |
| Date Mfgr Received | 2011-11-04 |
| Device Manufacturer Date | 2011-08-03 |
| Date Added to Maude | 2012-01-25 |
| 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 INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION (R) CLINICAL CHEMISTRY SYSTEM |
| Generic Name | DIMENSION(R) ACETAMINOPHEN FLEX? REAGENT CARTRIDGE |
| Product Code | LDP |
| Date Received | 2011-11-30 |
| Catalog Number | DF88 |
| Lot Number | CD2215 |
| Device Expiration Date | 2012-08-02 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-11-30 |