MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for MCKESSON CONSULT U120 manufactured by Acon Laboratories, Inc..
[134856360]
Reporting of this case is based on a call received from a doctor's office in (b)(6) who was having issues with their urine analyzer. Customer reported that their analyzer was reading negative for leukocytes but the patient was hospitalized the next day due to sepsis as a result of uti. In follow up communication for this case, the customer clarified that the lab result was negative for infection. According to the customer, the culture was drawn up within minutes and sent to the lab on the same day. Customer reported that hospitalized patient was treated at the hospital and is ok.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2531491-2019-00001 |
| MDR Report Key | 8299480 |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-03 |
| Date Mfgr Received | 2019-01-03 |
| Date Added to Maude | 2019-02-01 |
| 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. QIYI XIE |
| Manufacturer Street | 10125 MESA RIM RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588758000 |
| Manufacturer G1 | ACON LABORATORIES, INC. |
| Manufacturer Street | 10125 MESA RIM RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MCKESSON CONSULT U120 |
| Generic Name | URINE ANALYZER |
| Product Code | JRE |
| Date Received | 2019-02-01 |
| Returned To Mfg | 2019-01-23 |
| Model Number | U120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACON LABORATORIES, INC. |
| Manufacturer Address | 10125 MESA RIM ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-02-01 |