MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-20 for MEDITECH LABORATORY CLIENT SERVER RELEASE 5.67 manufactured by Medical Information Technology, Inc..
[102897497]
This event was not due to a software malfunction within the class i meditech lab product. It was due to a customer-defined calculation that the customer had written improperly. To minimize the risk of potential patient harm, meditech expects customers to validate customer-defined calculations in their test environment prior to use in a live environment. Per the college of american pathologists (cap), gen. 43450, laboratories are required to validate calculations involving reportable patient results. The calculations must be rechecked every two years (or when a system change is made) to ensure accuracy and records of the validation are retained. The validation should include laboratory informations systems, middleware and analyzers. The recommended workaround to prevent this issue from recurring is to inactivate the calculation until it can be reviewed, corrected, and validated in test before use in a live environment. In this instance, meditech reviewed the calculation with the customer on (b)(6) 2018 and assisted them in correcting the calculation so the results would be properly filed.
Patient Sequence No: 1, Text Type: N, H10
[102897498]
On (b)(6) 2018 a customer reported an incorrect result filed to the creatine kinase (ck) test in their meditech laboratory live environment. Meditech investigated the reported issue and determined the result of "<5" was filed due to a user-defined error through a customer defined calculation. As the result was reported by the customer-defined calculation as normal, no intervention was taken, which led to the patient ultimately being found unconscious. The patient's initial ck level was "2700" and when the patient was found unconscious it was "7000".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009404844-2018-00001 |
| MDR Report Key | 7352962 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-20 |
| Date of Report | 2018-03-06 |
| Date Mfgr Received | 2018-03-21 |
| Date Added to Maude | 2018-03-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MIKE HOCHELLA |
| Manufacturer Street | MEDITECH CIRCLE |
| Manufacturer City | WESTWOOD, |
| Manufacturer G1 | MEDICAL INFORMATION TECHNOLOGY, INC. |
| Manufacturer Street | MEDITECH CIRCLE |
| Manufacturer City | WESTWOOD, |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDITECH LABORATORY |
| Generic Name | MEDITECH LABORATORY SOFTWARE |
| Product Code | MMH |
| Date Received | 2018-03-20 |
| Model Number | CLIENT SERVER RELEASE 5.67 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INFORMATION TECHNOLOGY, INC. |
| Manufacturer Address | MEDITECH CIRCLE WESTWOOD, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-20 |