MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-02-07 for DIMENSION? DF167 SMN10444957 manufactured by Siemens Healthcare Diagnostics Inc.
[138119568]
The customer contacted a siemens customer care center (ccc) for the falsely depressed total bilirubin (tbi) result. The customer stated that the 12:13 pm patient sample was laid down next to the patient under the phototherapy light for some time and a physician questioned whether it may have degraded the tbi in the sample. Siemens headquarters support center (hsc) has reviewed the information provided and concludes that this event is not a reagent lot or assay issue. Quality control was within range at the time of the event. The dimension tbi reagent cartridge instructions for use states the following in the specimen collection and handling section: "bilirubin is extremely photosensitive. Care should be taken to protect sample from both daylight and fluorescent light to avoid photodegradation. " the cause of the discordant tbi result is unknown. No product nonconformance was identified. The device is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[138119569]
A discordant depressed total bilirubin (tbi) result was obtained on a neonate patient sample on the dimension exl system. The result was reported to the physician who questioned the result. A new sample was drawn and processed and a higher result was obtained. There are no known reports of patient intervention or adverse health consequences due to the discordant tbi result. No corrected reported was issued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2019-00058 |
| MDR Report Key | 8317404 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2018-08-21 |
| Date Added to Maude | 2019-02-07 |
| 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 P.O. BOS 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 500 GBC DRIVE P.O. BOS 6101 |
| Manufacturer City | NEWARK 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 | DIMENSION? |
| Generic Name | DIMENSION? TBI TOTAL BILIRUBIN FLEX? REAGENT CARTRIDGE |
| Product Code | CIG |
| Date Received | 2019-02-07 |
| Catalog Number | DF167 SMN10444957 |
| Lot Number | EB9233 |
| Device Expiration Date | 2019-08-21 |
| 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. BOS 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-07 |