MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-01-28 for UNICEL? DXC 800 PRO SYNCHRON? CLINICAL SYSTEM A11812 manufactured by Beckman Coulter Inc..
[18531064]
On (b)(6) 2012 a patient was admitted to (b)(6) hospital with a question of paracetamol (actm-acetaminophen) overdose. Actm and salicylate (saly) tests were ordered and ran on the unicel dxc 800 pro synchron clinical system. The analyzer generated a false low actm result of 0. 1mg/l for this patient sample, which did not suggest overdose. The result was reported out of the laboratory. The patient was redrawn 12 hours later and tested for actm with a result of 12mg/l. Since this result didn't correlate with the original sample result, the original sample was rerun with a result of 197mg/l. The patient was then treated for paracetamol overdose. The saly test ordered on the same sample had a suppressed result and a pop-up on screen error message of "obstruction error". The sample was then placed on an alternate instrument to re-run the saly test. No details were provided about the results of the saly test; the saly results were not questioned. Per actm chemistry information sheet (cis), the therapeutic range for actm is 10-30ug/ml. Levels of >150ug/ml 4 hours post ingestion are considered hepatotoxic. It is unknown how long after ingestion the original sample was drawn. The low end of the analytical range is 0. 1ug/ml. The customer filed an mhra report, but did not report the event to beckman coulter inc. , (bec). Bec learned of the event on (b)(4) 2013 via the mhra report. The patient's treatment for paracetamol overdose was delayed by 12 hours. In this case, the patient did not suffer any ill effects from the delay; liver function tests were normal. Reagent used: commercial name: synchron acetaminophen 1x100 test kit; catalogue number: 472169; lot number: m109240; manufacture date: 12-15-2011; expiration date: 12-31-2013.
Patient Sequence No: 1, Text Type: D, B5
[18683264]
Qc prior to and after the event exhibited acceptable precision. Historical data shows that recovery was within acceptable range of the running mean and within acceptable precision per the actm cis total precision claim. A field service engineer (fse) was dispatched once bec was notified of the event from mhra. Review of the system event logs by the fse confirmed that the likely failure mode was an insufficient sample pipetted. The fse confirmed that the rerun sample was poured off into a micro tube, which is only done in this laboratory when there is a small amount of sample remaining. It is likely that there was an insufficient sample volume for the tube in use. This would cause the probe to sense liquid (no flag), but due to insufficient volume, the probe would enter the gel and become obstructed (causing the saly test to flag). The fse tested the obstruction detection system and confirmed it was performing as expected. A precision run gave acceptable precision results. No system malfunction was found. As of (b)(4) 2013, the fse confirmed there have been no more occurrences. The actm data was forwarded to bec for investigation. The plot of the false low actm result indicates that insufficient sample was injected into the reaction cuvette. Based on the event evaluation, cause of this incident is a use error (insufficient sample volume in the sample tube), but this was not confirmed by the customer. The fse evaluated the system and found no reasonable evidence of a malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00028 |
| MDR Report Key | 2930600 |
| Report Source | 01,05,06 |
| Date Received | 2013-01-28 |
| Date of Report | 2013-01-03 |
| Date of Event | 2012-12-23 |
| Date Mfgr Received | 2013-01-03 |
| Device Manufacturer Date | 2007-03-06 |
| Date Added to Maude | 2013-01-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 800 PRO SYNCHRON? CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | LDP |
| Date Received | 2013-01-28 |
| Model Number | DXC 800 PRO |
| Catalog Number | A11812 |
| Lot Number | SW VERSION 4.9.0 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2013-01-28 |