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 2020-01-06 for ALINITY C CALCIUM REAGENT 07P5720 07P57-20 manufactured by Abbott Gmbh.
[188236271]
Complete information for section a. Patient information, 1. Patient identifier = sid685063673301 an evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no further patient information provided due to privacy issues.
Patient Sequence No: 1, Text Type: N, H10
[188236272]
The customer reported falsely elevated calcium results on one male patient generated on the alinity c analyzer. The results generated were: on (b)(6) 2019 sid685063673301 on serial number (b)(4) = 5. 8490mmol/l (normal range 2. 15-2. 50mmol/l) / retest on sn (b)(4) = 4. 8167 / sn (b)(4) = >6. 0; the sample was then poured into cups - serum on sn (b)(4) = 3. 9814mmol/l / plasma 3. 8804 / plasma on sn (b)(4)= 3. 7996mmol/l; new sample drawn = 3. 99mmol/l / tested on abl800 analyzer = 2. 25mmol/l. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2020-00012 |
| MDR Report Key | 9554429 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-06 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-02-25 |
| Date Added to Maude | 2020-01-06 |
| 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 CALCIUM REAGENT |
| Generic Name | CALCIUM |
| Product Code | CJY |
| Date Received | 2020-01-06 |
| Model Number | 07P5720 |
| Catalog Number | 07P57-20 |
| Lot Number | 63032UN18 |
| Device Expiration Date | 2019-12-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-06 |