MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-24 for RAPIDPOINT 500 BLOOD GAS ANALYZER 10697306 manufactured by Siemens Healthcare Diagnostics.
[180903343]
The customer stated that this low thb result was not reported so the patient's treatment was not affected. Also stated was irregularities were observed in the sample collection process such as improperly mixed samples. In the events log, there were several "d39 clot detected" errors found. The log files were received for investigation. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[180903344]
The customer reported an unusually low total hemoglobin result on the rp 500. The customer did not repeat the test and stated the result was expected to be the normal range. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00006 |
| MDR Report Key | 9746469 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-02-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | FELIX AKINRINOLA |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 7052212 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | NORTHERN ROAD CHILTON INDUSTRIAL ESTATE |
| Manufacturer City | SUDBURY, CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDPOINT 500 BLOOD GAS ANALYZER |
| Generic Name | RP 500 |
| Product Code | CHL |
| Date Received | 2020-02-24 |
| Catalog Number | 10697306 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |