MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-04 for STAT PROFILE CRITICAL CARE XPRESS 37413 37272 manufactured by Nova Biomedical.
[1870934]
Per the customer, a patient whole blood samples that were analyzed on a specific critical care xpress analyzer were recovering ionized calcium results that were clinically significantly lower than other critical care xpress analyzers within the same laboratory. Result comparison: affected analyzer: 0. 62; other analyzer in lab: 1. 22; affected analyzer: 0. 57; other analyzer in lab: 1. 24; affected analyzer: 0. 58, other analyzer in lab: 1. 18. Quality control results on applicable analyzers were in compliance. The patient's results were reported but no action was done for patient based on the results. A support call was performed on the affected analyzer which included replacement of the ionized calcium sensor. All comparisons were acceptable. The calcium sensor from the affected analyzer was returned to nova biomedical for investigation. The investigation did not confirm the complaint of low whole blood calcium results. As of (b)(4) 2011, there have been no further reports from the customer for low calcium results since the support call.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219029-2011-00002 |
| MDR Report Key | 2057139 |
| Report Source | 05 |
| Date Received | 2011-03-04 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-02-04 |
| Date Mfgr Received | 2011-02-09 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2011-09-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAUL MCDONALD, CHIEF Q OFFICER |
| Manufacturer Street | 200 PROSPECT ST. |
| Manufacturer City | WALTHAM MA 02454 |
| Manufacturer Country | US |
| Manufacturer Postal | 02454 |
| Manufacturer Phone | 7816473700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAT PROFILE CRITICAL CARE XPRESS |
| Generic Name | BLOOD GAS/ELECTROLYT/METABOLITE ANALYZER |
| Product Code | JFP |
| Date Received | 2011-03-04 |
| Returned To Mfg | 2011-02-14 |
| Model Number | 37413 |
| Catalog Number | 37272 |
| Lot Number | Y03110160 |
| Device Expiration Date | 2011-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVA BIOMEDICAL |
| Manufacturer Address | 200 PROSPECT ST. WALTHAM MA 02454 US 02454 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-04 |