MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for DRAGER JAUNDICE METER, MODEL JM-103 MU20606 manufactured by Draeger Medical Systems, Inc..
[110231627]
Patient Sequence No: 1, Text Type: N, H10
[110231628]
The meter (jm-103) has a value of 1- that indicates one more flash needs to be completed before the numbers can be averaged and the result is calculated. The problem is that this number has the mg/dl under it which makes it really seem like a result...... Extremely easy to misread and i'm surprised this doesn't happen more often. Granted, the second screen does have 2 dashes before the value and isn't in a decimal format, but still potential for error (obviously).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7573133 |
| MDR Report Key | 7573133 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-05-22 |
| Report Date | 2018-05-22 |
| Date Reported to FDA | 2018-05-22 |
| Date Reported to Mfgr | 2018-05-22 |
| Date Added to Maude | 2018-06-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGER JAUNDICE METER, MODEL JM-103 |
| Generic Name | BILIRUBIN METER |
| Product Code | MQM |
| Date Received | 2018-06-06 |
| Model Number | MU20606 |
| Catalog Number | JM-103 |
| Lot Number | NA |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3135 QUARRY ROAD TELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-06 |