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 2020-03-11 for RAPIDLAB 1265 BLOOD GAS ANALYZER 10321852 manufactured by Siemens Healthcare Diagnostics.
[182930880]
The customer stated that repeat testing was performed to confirm correct results which met the clinical condition of the patient. Siemens service communicated with the customer the following morning after the event to assess instrument performance. The customer had replaced the lactate sensor. A field service engineer (fse) went onsite to export log files and gather additional information. According to the fse, the high gl and qc results were in the expected ranges after the lactate sensor replacement. Siemens has requested the original lactate sensor to be returned but it is not available, and the log files for investigation.
Patient Sequence No: 1, Text Type: N, H10
[182930881]
The customer reported discrepant low lactate results from one patient on the rl 1265 when compared to the lactate results on the rp 500. The customer stated the patient was in critical condition and admitted to the icu for several days prior to the event. The patient had sepsis which rapidly progressed. The customer indicated the patient is deceased. Safety data information from the complaint states that the customer in not alleging harm to the patient due to the use of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2020-00009 |
| MDR Report Key | 9817843 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Model Number | 10321852 |
| Catalog Number | 10321852 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-11 |