MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-07 for SYVA? EMIT 10445369 6M119UL SMN 10445369 manufactured by Siemens Healthcare Diagnostics Inc..
[173917691]
The customer contacted the siemens healthcare diagnostics customer care center (ccc) to report that a discordant depressed siemens emit lidocaine result was obtained on a patient sample while using a non-siemens instrument. The customer, (b)(6) medical laboratory, stated that patient sample (b)(6) was collected at an alternate facility, (b)(6) hospital, and transferred to (b)(6) medical laboratory for testing and reporting. It is unknown if any lidocaine testing was performed at (b)(6) hospital. On (b)(6) 2019, user reported issue with falsely low (negative) lidocaine results for one patient's samples tested on a beckman coulter au680? Analyzer, with the siemens syva emit lidocaine assay, lot m1. Two samples were affected from the same patient on two consecutive samples; sample 1, collected at 03:27a on (b)(6) 2019 and sample 2, collected at 17:00p on (b)(6) 2019. Initial results were reported to the physician. Pharmacist questioned these results days later on (b)(6) 2019, as higher results were to be expected. Laboratory then repeated the original patient samples and obtained higher lidocaine values, corrected reports were issued. The patient expired before the results of the 17:00p (b)(6) 2019 sample were reported. Siemens is investigating the event. It is not known if the discrepant results were due to the siemens syva emit lidocaine reagent or the beckman coulter au680? Instrument or some other reason. Mdr 2517506-2020-00002 was filed for patient test results obtained on (b)(6) 2019.
Patient Sequence No: 1, Text Type: N, H10
[173917692]
It was reported that a discordant depressed lidocaine result was obtained on a patient sample processed (b)(6) 2019 on a non-siemens instrument using the siemens syva emit lidocaine reagent. The discordant result was reported to the physician. The customer stated that the discordant initial lidocaine result was reported to the physician. The customer informed siemens that on a later date (and subsequent to the death of the patient) a pharmacist questioned the depressed lidocaine result and the same patient sample was reprocessed at that time using the same siemens syva emit lidocaine reagent on the same non-siemens system. A higher result was obtained and a corrected report was issued. The customer stated that the patient expired on (b)(6) 2019. The exact time of the patient expiration has not been provided. The customer informed siemens that the laboratory pathologist stated that the pathologist report at the hospital where the patient expired indicated that "the death was cardiac arrest most likely due to lidocaine toxicity. " the customer stated that lidocaine quality control results were within laboratory reference ranges on the date of testing. Statements and actions attributed to the physician(s) and customer are derived from the information supplied by the customer to siemens, documented in siemens complaint handling system and have not been verified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2020-00003 |
| MDR Report Key | 9557725 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-07 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2019-02-26 |
| Date Added to Maude | 2020-01-07 |
| 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 | JAMES MORGERA |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK, DE DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK, DE DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYVA? EMIT |
| Generic Name | SYVA? EMIT LIDOCAINE ASSAY |
| Product Code | KLR |
| Date Received | 2020-01-07 |
| Model Number | 10445369 |
| Catalog Number | 6M119UL SMN 10445369 |
| Lot Number | M1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-07 |