[59017532]
On september 22, 2016, mid america clinical lab located in (b)(6) notified data innovations llc that pt results from the sebia phoresis instrument were not crossing correctly from data innovations' instrument manager to the lab info system (lis). Upon investigation, it was discovered that the sebia phoresis instrument was intermittently sending the result message incorrectly to instrument manager. Sebia phoresis instrument sends the result message in a fixed width format. But intermittently the instrument does not send the result message in the same format, causing some of the results to be incorrect. The sebia phoresis instrument protocol is a positional based protocol (does not use any delimiters) and is also variable in length. The message is variable in length and the variable fields are at the end of the message. In this case, sebia phoresis instrument appears to have removed text in the middle of the message skewing the location of the individual results in the message. Because of this, there is no way to detect this issue or protect the parsing of data in the instrument manager driver and to throw an error message. This is not a malfunction of instrument manager. Mid america clinical lab stated no pts were harmed as all results were verified and correct prior to sending to pt record. Issue is being reported because it is unk if there is a malfunction in the sebia phoresis instrument that could occur again and at other sites, potentially causing incorrect results to be reported. Sebia phoresis was notified by macl prior to october 10, 2016. Data innovations contacted sebia phoresis on october 19, 2016 to notify of this potential malfunction of their instrument. Sebia phoresis is investigating this issue.
Patient Sequence No: 1, Text Type: D, B5