MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-01-30 for STAT PROFILE PRIME PLUS ANALYZER SYSTEM 57400 manufactured by Nova Biomedical Corp.
[183878060]
Device investigation: a dhr review was performed by the quality control engineer and included an assessment of the production, testing, and release of the analyzer. No abnormalities or concerns were observed; the dhr indicated that the released product met all specifications. The customer database was reviewed and no issues were found. Nova application specialist went onsite to perform correlation to customer's reference method. The correlation data demonstrated that the analyzer performs as intended. Local distributor representatives visited the site and reviewed both patient and qc results of the concerning day and the following days together with the hospital's point of care (poc) coordinator. All qc results were inside the qc ranges and the patient results correlated as expected to lab hematology analyzer. During series of visits, local distributor noticed that the sample handling of some operators was not ideal. Samples were not always being mixed prior to analysis and clot catchers are not always used. The root cause for high hb and hct results is determined to be improper sample handling. Lack of homogeneity of a blood sample can lead to incorrect results. Immediate mixing of the sample upon blood collection insures that the anticoagulant in the specimen container has fully dissolved with the blood, thus maintaining not only the effective anticoagulant-to-blood ratio but also providing a specimen free from any blood clots. Because blood cells naturally sediment, a prior thorough mixing of the blood in the tube is necessary to ensure accurate reading.
Patient Sequence No: 1, Text Type: N, H10
[183878061]
Customer reported high hemoglobin and hematocrit patient results using nova prime plus analyzer when compared to lab reference method. No harm or inappropriate treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219029-2020-00004 |
| MDR Report Key | 9646478 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MARIYA CESNULEVICIUS |
| Manufacturer Street | 200 PROSPECT ST. |
| Manufacturer City | WALTHAM MA 024543654 |
| Manufacturer Country | US |
| Manufacturer Postal | 024543654 |
| Manufacturer Phone | 7816473700 |
| Manufacturer G1 | NOVA BIOMEDICAL CORP. |
| Manufacturer Street | 200 PROSPECT ST. |
| Manufacturer City | WALTHAM MA 024543465 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 024543465 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAT PROFILE PRIME PLUS ANALYZER SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | GKR |
| Date Received | 2020-01-30 |
| Model Number | 57400 |
| Catalog Number | 57400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVA BIOMEDICAL CORP |
| Manufacturer Address | 200 PROSPECT ST. WALTHAM MA 024543654 US 024543654 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |