MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-21 for LABCORP, GROWTH HORMONE, SERUM TEST # 004275 TEST# 004275 manufactured by Labcorp.
[682690]
This is in reference to labcorp growth hormone, serum test number 004275. According to the reference ranges provided by facility, the range of 0. 0-6. 0 is considered normal for an adult male; however, it seems that the reference 0. 0 is not correct because it would indicate no evidence of a gh present therefore the test can not yield a negative/deficient result. Case in question yields a result of 0. 3 which we consider low or deficient. According to the reference results by facility, there is no manner in which a person can be considered gh deficient because the results can not equal lower than 0. 0. The test should yield a reference range of something higher than 0. 0, so that the end result would prove or disprove gh deficiency. Http://www. Labcorp. Com/datasets/labcorp/html/chapter/mono/sr002300. Htm
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003493 |
| MDR Report Key | 902155 |
| Date Received | 2007-08-21 |
| Date of Report | 2007-08-21 |
| Date of Event | 2007-08-21 |
| Date Added to Maude | 2007-09-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABCORP, GROWTH HORMONE, SERUM TEST # 004275 |
| Generic Name | GROWTH HORMONE TEST |
| Product Code | CFL |
| Date Received | 2007-08-21 |
| Model Number | TEST# 004275 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 881254 |
| Manufacturer | LABCORP |
| Manufacturer Address | BIRMINGHAM AL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2007-08-21 |