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 2020-02-19 for RAPIDLAB 1265 BLOOD GAS ANALYZER 10321852 manufactured by Siemens Healthcare Diagnostics.
[180902972]
Siemens reviewed the data logs provided by the customer. The co-oximetry functionality on the rl1265 appears to have been working as intended throughout the day of and including when the sample in question was measured. This is concluded based on the co-ox calibration stability, internal co-ox quality checks, aqc expected recovery and lack of any relevant diagnostic errors or exception flags. The reported thb values appear valid. It is known that for accurate thb measurements, whole blood specimens require the red blood cells to be uniformly distributed throughout the entire sample. This can be obtained only by thorough mixing of the blood sample across two planes performed immediately before each analysis. Service discussed the importance of pre-analytical concerns with the customer. The instrument is operational. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[180902973]
The customer reported discrepant total hemoglobin results on the rl 1265. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00004 |
| MDR Report Key | 9729533 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-19 |
| 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 | RAPIDLAB 1265 BLOOD GAS ANALYZER |
| Generic Name | RL 1265 |
| Product Code | CHL |
| Date Received | 2020-02-19 |
| Model Number | 10321852 |
| Catalog Number | 10321852 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-02-19 |