MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for JAUNDICE METER JM103 UNK manufactured by Draeger Medical Systems, Inc..
[105873925]
There is no indication that the meter did not function as intended. The users in this case misinterpreted the displayed "---" as the meter being defective. After consulting the instructions for use, they found that the displayed "---" meant the reading was out of range. Draeger has initiated a field action.
Patient Sequence No: 1, Text Type: N, H10
[105873926]
Due to a processing error, this mdr is being submitted late. The customer reported that during use on a patient with a family history of jaundice and yellowing of the skin noted by patients mother, due to a user misunderstanding of an out of range reading ("---") on the jaundice meter, there was a delay in treatment (phototherapy, anticonvulsant drugs, and blood transfusion). It was reported that the patient suffered brain damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2510954-2018-00002 |
| MDR Report Key | 7441559 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-06-13 |
| Date of Event | 2015-03-17 |
| Date Mfgr Received | 2017-05-18 |
| Date Added to Maude | 2018-04-18 |
| 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 | MR. DHAVAL TRIVEDI |
| Manufacturer Street | 3135 QUARRY ROAD |
| Manufacturer City | TELFORD PA 18969 |
| Manufacturer Country | US |
| Manufacturer Postal | 18969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1220063-04/17/2018-001-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JAUNDICE METER |
| Generic Name | NON-INVASIVE TRANSCUTANEOUS BILIRUBINOMETER |
| Product Code | MQM |
| Date Received | 2018-04-18 |
| Model Number | JM103 |
| Catalog Number | UNK |
| Lot Number | N/A |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Deathisabilit | 2018-04-18 |