MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-26 for ALINITY C PROCESSING MODULE 03R6701 03R67-01 manufactured by Abbott Gmbh.
[185107220]
Patient information: no further patient information was provided by the customer. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[185107221]
The customer observed falsely decreased alinity c calcium results for 2 samples. The following data was provided (units of measure = mmol/l): sample 1: initial calcium result = 0. 89, repeat = 2. 32, repeat on another analyzer = 2. 30. Sample 2: initial calcium result = 1. 01, repeat = 1. 85, repeat on another analyzer = 1. 93. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2020-00219 |
| MDR Report Key | 9885153 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-08 |
| Date Mfgr Received | 2020-03-08 |
| Date Added to Maude | 2020-03-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | ABBOTT GMBH |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALINITY C PROCESSING MODULE |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2020-03-26 |
| Model Number | 03R6701 |
| Catalog Number | 03R67-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GMBH |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |