MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-25 for INSTRUMENT MANAGER SOFTWARE 8.12.12 manufactured by Data Innovations Llc.
[83876386]
Customer reported an issue where a rule was changing the result of microalbumin. If the instrument passed instrument manager a result which was outside of the instrument's reporting range (ex: ">200") the rule was changing the result to "<5". The rule was written incorrectly due to the omission of an "is numeric" qualifier. The rule was in place for over 8 years. At this time, no patient safety issues have been reported, but due to the length of time the incorrect rule was in place, data innovations is reporting the issue while further investigation takes place to identify if patient harm occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225673-2017-00002 |
| MDR Report Key | 6822179 |
| Date Received | 2017-08-25 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2013-12-11 |
| Date Added to Maude | 2017-08-25 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DAVID RUSSO |
| Manufacturer Street | 120 KIMBALL AVE SUITE 100 |
| Manufacturer City | SOUTH BURLINGTON VT 05403 |
| Manufacturer Country | US |
| Manufacturer Postal | 05403 |
| Manufacturer Phone | 8026582850 |
| Manufacturer G1 | DATA INNOVATIONS LLC |
| Manufacturer Street | 120 KIMBALL AVE SUITE 100 |
| Manufacturer City | SOUTH BURLINGTON VT 05403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 05403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INSTRUMENT MANAGER SOFTWARE |
| Generic Name | SOFTWARE, BLOOD BANK, STAND ALONE |
| Product Code | MMH |
| Date Received | 2017-08-25 |
| Model Number | 8.12.12 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATA INNOVATIONS LLC |
| Manufacturer Address | 120 KIMBALL AVE SUITE 100 SOUTH BURLINGTON VT 05403 US 05403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-25 |