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 2017-09-14 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[87228433]
A siemens customer service engineer (cse) was at the customer site regarding an unrelated service event when this issue occurred. The cse observed that the sample probe tubing was pinched in half. The cse repaired it and cleared the obstruction from the tubing. The customer ran quality control (qc) and additional patient samples, resulting satisfactory. A siemens headquarters support center specialist (hsc) reviewed the instrument data and concluded that there is no evidence of a reagent or method issue and no evidence of a product nonconformance. The data is consistent with instrument related issues associated with improper sampling such as intermittent or inconsistent sampling of specimens. The cause of the discordant, falsely elevated glucose result is associated with inconsistent sampling caused by the obstructed tubing. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[87228434]
A discordant, falsely elevated glucose (glu) result was obtained on a patient sample on a dimension exl with lm instrument. The discordant result was reported to the physician(s) who questioned it. The sample was repeated on an alternate dimension exl instrument, resulting lower. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated glu result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00705 |
| MDR Report Key | 6866260 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-08-20 |
| Date Mfgr Received | 2017-08-20 |
| Device Manufacturer Date | 2013-11-21 |
| Date Added to Maude | 2017-09-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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. MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | REGISTRATION #: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION EXL WITH LM |
| Generic Name | DIMENSION EXL WITH LM |
| Product Code | CFR |
| Date Received | 2017-09-14 |
| Model Number | DIMENSION EXL WITH LM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE P.O. BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION EXL WITH LM |
| Generic Name | DIMENSION EXL WITH LM |
| Product Code | JJE |
| Date Received | 2017-09-14 |
| Model Number | DIMENSION EXL WITH LM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE P.O. BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-14 |