MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-16 for API 3200MD SYSTEM API3200MD 5024543 manufactured by Ab Sciex.
[92983699]
There was no indication of patient injury or death. The event happened during testing of control samples. If this were to re-occur on actual patient samples there is a potential for wrong results which could lead to delayed results/misdiagnosis. The investigation of the complaint is ongoing and a follow up report will be submitted should additional information become available.
Patient Sequence No: 1, Text Type: N, H10
[92983700]
The instrument involved, a api 3200md lc-ms/ms system, had shown high background noise for the methionine d3 analyte. The software, chemoview md v2. 0. 3, was no longer able to recognize the signal peaks for the methionine d3 analyte due to this background noise. During a repair attempt the customer ran four quality controls to test the system. One quality control failed on one analyte due to spike of background noise at start of injection. This caused chemoview md to give the wrong result. It was mentioned by the customer that if this had occurred during an actual patient sample run, it might have gone unnoticed. The customer was using this instrument to run newborn screening tests using the chromsystems newborn screening kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008935545-2017-00001 |
| MDR Report Key | 7039888 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-16 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-10-19 |
| Date Mfgr Received | 2017-10-19 |
| Device Manufacturer Date | 2004-08-13 |
| Date Added to Maude | 2017-11-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MS. NICHOLE RIEK |
| Manufacturer Street | 500 OLD CONNECTICUT PATH |
| Manufacturer City | FRAMINGHAM MA 01701 |
| Manufacturer Country | US |
| Manufacturer Postal | 01701 |
| Manufacturer Phone | 5083837217 |
| Manufacturer G1 | AB SCIEX PTE LTD |
| Manufacturer Street | BLK 33, #04-06 MARSILING INDUSTRIAL ESTATE |
| Manufacturer City | SINGAPORE 739256 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 739256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | API 3200MD SYSTEM |
| Generic Name | LC-MS/MS |
| Product Code | NQL |
| Date Received | 2017-11-16 |
| Model Number | API3200MD |
| Catalog Number | 5024543 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AB SCIEX |
| Manufacturer Address | 500 OLD CONNECTICUT PATH FRAMINGHAM MA 01701 US 01701 |
| Brand Name | API 3200MD SYSTEM |
| Generic Name | LC-MS/MS |
| Product Code | DOP |
| Date Received | 2017-11-16 |
| Model Number | API3200MD |
| Catalog Number | 5024543 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AB SCIEX |
| Manufacturer Address | 500 OLD CONNECTICUT PATH FRAMINGHAM MA 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-16 |